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Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies

Primary Purpose

Hematologic Neoplasms

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
donor lymphocyte infusion
Cyclophosphamide
Busulfan
Mycophenolate mofetil
Fludarabine
Sirolimus
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Neoplasms focused on measuring Prophylactic Donor Lymphocyte Infusions, Chronic Graft-Versus-Host Disease, Immunotherapeutic Strategies, myeloablative conditioning, Steroid-Refractory Grade

Eligibility Criteria

12 Years - 120 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers
  • INCLUSION CRITERIA:

Inclusion Criteria - Recipient

  • Histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk by the Refined Disease Risk Index for HCT including one of the following:
  • Acute myeloid leukemia (AML) with favorable cytogenetics (t(8;21), inv(16), t(15,17)) with induction failure (persistent disease without first achieving remission of any type) or active relapse
  • AML with intermediate cytogenetics (not classified as favorable or adverse) with induction failure or active relapse (AML with intermediate cytogenetics in morphologic complete remission [CR] with minimal residual disease detectable by any modality also will be eligible)
  • AML with adverse cytogenetics (complex karyotype with >= 4 abnormalities) regardless of remission status
  • Low risk myelodysplastic syndrome (MDS) (<= 5% blasts, including chronic myelomonocytic leukemia) with adverse cytogenetics (abnormal chromosome 7 or >= 4 abnormalities) with induction failure or active relapse
  • High risk MDS (RAEB-1 or RAEB-2) with intermediate-risk cytogenetics (no abnormal chromosome 7 or < 4 abnormalities) with induction failure or active relapse
  • High risk MDS (RAEB-1 or RAEB-2) with adverse cytogenetics (abnormal chromosome 7 or >= 4 abnormalities) regardless of remission status
  • Acute lymphoblastic leukemia (ALL) in CR >= 2 or with induction failure or active relapse (ALL in CR1 with minimal residual disease detected also will be eligible)
  • Chronic myelocytic leukemia (CML) in blast crisis phase
  • Hodgkin lymphoma with stable or progressive disease
  • Mantle cell lymphoma with stable or progressive disease
  • Relapsed Burkitt lymphoma in CR or partial remission (PR)
  • Aggressive B-cell Non-Hodgkin Lymphoma (NHL) (e.g., diffuse large B-cell lymphoma, transformed indolent B-cell lymphoma) with stable or progressive disease
  • T-cell NHL with stable or progressive disease
  • Multiple myeloma (MM) with induction failure as defined by failure to achieve minimal response (CR, Very Good Partial Response [VGPR], or PR) or the development of progressive disease on primary therapy, or MM with active relapse as defined by previously treated myeloma that achieved a molecular response or better that then progressed
  • Age 18-65 years.
  • At least one potentially suitable HLA-haploidentical or HLA-matched donor
  • Karnofsky performance score >=60%
  • Recipient participants must have adequate organ function as defined below:
  • Cardiac ejection fraction >=45% by 2D ECHO;
  • Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of >=50% predicted;
  • Estimated serum creatinine clearance of >=60 ml/minute/1.73m2 calculated using eGFR in the clinical lab;
  • Total bilirubin <=2X the upper limit of normal;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3X the upper limit of normal.
  • Myeloablative conditioning is toxic to the developing human fetus and is teratogenic. For this reason, the following measures apply:
  • Women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one-year post-transplant.
  • WOCBP must have a negative serum or urine pregnancy test within 7 days prior to enrollment.

Inclusion Criteria - Donor

-Related donor (age >=12) deemed suitable, eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood, bone marrow, and stool for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.

EXCLUSION CRITERIA:

Exclusion Criteria - Recipient

  • Subjects who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 3 weeks prior to the date of beginning conditioning.
  • Prior myeloablative conditioning for autologous or allogeneic HCT.
  • Active breastfeeding.
  • Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is metastatic, relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment. This excludes non-melanoma skin cancers.
  • Uncontrolled intercurrent illness (e.g. severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active hepatitis, uncontrolled dental infection) that in the opinion of the PI would make it unsafe to proceed with transplantation.

Exclusion Criteria - Donor

None.

Sites / Locations

  • National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Donor Arm

Phase I Dose Escalation, Cohort 1 (matched)

Phase I Dose Escalation, Cohort 2 (haploidentical)

Phase II Efficacy, Cohort 1 (matched)

Phase II Efficacy, Cohort 2 (haploidentical)

Arm Description

Donors for Recipients in Arms 1-4

DLI at escalating doses (1 x 10^6 CD3+ cells/kg, 3 x 10^6 CD3+ cells/kg, and 1 x 10^7 CD3+ cells/kg) on day +7 or +21 to assess for safety and determine Phase II dose (up to 18 evaluable patients)

DLI at escalating doses (1 x 10^5 CD3+ cells/kg, 3 x 10^5 CD3+ cells/kg, and 1 x 10^6 CD3+ cells/kg) on day +7 or +21 to assess for safety and determine Phase II dose (up to 18 evaluable patients)

DLI at maximally tolerated, safe dose (from Phase I) to assess secondary clinical outcomes at this dosing level (up to 14 additional evaluable patients in each cohort)

DLI at maximally tolerated, safe dose (from Phase I) to assess secondary clinical outcomes at this dosing level (up to 14 additional evaluable patients in each cohort)

Outcomes

Primary Outcome Measures

determine the maximally tolerated dose of DLI that can be safely administered after HLA-matched-related HCT and after HLA-haploidentical HCT
fraction of evaluable patients who experience steroid-refractory grade III-IV aGVHD at day +60 will be determined and reported along with 80% and 95% two-sided confidence intervals.

Secondary Outcome Measures

determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of Steroid-refractory Grades II-IV and Grades III-IV aGVHD at days +100 and +200 for HLA-matched-related and HLA-haploidentical
To evaluate steroid-refractory grade II-IV and grade III-IV acute GVHD at day 100 and 200.
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of chronic GVHD at 1 year for HLA-matched-related and HLA-haploidentical
To evaluate chronic GVHD
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of Grades II-IV and Grades III-IV aGVHD at days +100 and +200 for HLA-matched-related and HLA-haploidentical
To evaluate grade II-IV and grade III-IV acute GVHD at day 100 and 200.
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of non-relapse mortality at 100 days and 1 year for HLA-matched-related and HLA-haploidentical
To evaluate non-relapse mortality
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of relapse at 1 year for HLA-matched-related and HLA-haploidentical
To evaluate relapse
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of overall survival (OS) and disease-free survival (DFS) at 1 year for HLA-matched-related and HLA-haploidentical
To evaluate survival
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of primary engraftment (including time to neutrophil and platelet engraftment) for HLA-matched-related and HLA-haploidentical
Rate and timing of neutrophil and platelet engraftment reported as median engraftment times for each and cumulative incidences of each at days +28 and +100

Full Information

First Posted
April 7, 2022
Last Updated
August 29, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05327023
Brief Title
Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
Official Title
Phase I/II Study Using Prophylactic Donor Lymphocyte Infusion Early Post-Transplant After Allogeneic Hematopoietic Cell Transplantation Using Post-Transplantation Cyclophosphamide for High-Risk Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
August 28, 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
July 3, 2028 (Anticipated)
Study Completion Date
July 2, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high. Researchers want to see if giving the transplant recipient an infusion of lymphocytes (a type of white blood cell) from their transplant donor early after the transplant can reduce that risk. Objective: To learn if giving donor lymphocytes early after a transplant will help reduce the risk of relapse for people with certain blood cancers. Eligibility: Adults aged 18-65 with high-risk leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma that does not respond well to standard treatments and/or has a high risk of relapse. Healthy potential bone marrow and lymphocyte donor relatives aged 12 and older are also needed. Design: Participants will be screened with: Physical exam Blood and urine tests Spinal tap Eye exam Dental exam Heart and lung tests Imaging scans. A radioactive substance may be injected in their arm if a PET scan is needed. Bone marrow aspiration and biopsy Some screening tests will be repeated during the study. Participants will stay at the NIH hospital for about 4 weeks. They will receive a central venous catheter. They will get chemotherapy and other drugs starting 6 days before transplant. Then they will have their transplant. They will receive donor white blood cells 7 days later. They will give blood, bone marrow, urine, and stool samples for research. They must stay near NIH for at least 100 days after transplant. Participants will have periodic follow-up visits for 5 years. Healthy donors will have 2-3 visits. They will give blood, bone marrow, white blood cells, and stool samples for research. Participation will last for 5 years.
Detailed Description
Background: High-risk hematologic malignancies generally are incurable without an allogeneic hematopoietic cell transplant (HCT), but even HCT is associated with high risk of relapse and very poor overall survival. Prophylactic donor lymphocyte infusions (DLI) have been used to prevent relapse in high-risk diseases; preemptive DLIs have been used for MRD positivity or decreasing donor chimerism post-transplant; and, therapeutic DLIs have been used to treat overt morphologic relapse post-transplant. Prophylactic, preemptive, and therapeutic DLIs can cause significant graft-versus-host disease (GVHD), both acute and chronic, based on the dose of lymphocytes, timing of the infusion, and use of preparative chemotherapy, although these same factors also may impact on the therapeutic efficacy (graft-versus-tumor immunity of the DLI). Post-transplantation cyclophosphamide (PTCy) reduces rates of severe acute and chronic graft-versus-host disease (GVHD) and the immunosuppressive burden after HCT. In pre-clinical HCT models, very large DLI doses can be given after PTCy, even as early as 24 hours after PTCy treatment, and significant GVHD is not induced, different from that seen for DLI infusions in mice treated with T-cell-depleted HCT, in which fatal GVHD is rapidly induced. This effect in PTCy-treated mice is dependent on Foxp3+ regulatory T cells. In patients treated at the NIH Clinical Center, DLI has been given for clinical reasons as early as 1 month post-transplant in PTCy-treated patients for infection, falling chimerism, or relapse and did not cause GVHD in these settings when additional conditioning was not given and T-cell-depleting antibodies were not used, both of which may disrupt the regulatory mechanisms induced after PTCy that are needed to control GVHD. The early integration of immunotherapeutic strategies, such as DLIs, after PTCy has the potential to prevent relapse in patients with high-risk hematologic malignancies, which may result in improved survival in such patients. Objectives: -To determine the maximally tolerated dose of DLI that can be safely administered after HLA-matched-related HCT and after HLA-haploidentical HCT Eligibility: -Recipient Participant: Histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk by the Refined Disease Risk Index for HCT Age 18-65 At least one potentially suitable human leukocyte antigen (HLA)-matched related or HLA-haploidentical donor. Karnofsky performance score >=60 Adequate organ function Design: Open-label, single-center, non-randomized, phase I/II study All recipient participants will receive myeloablative conditioning, HLA-matched-related or HLA-haploidentical bone marrow HCT, GVHD prophylaxis including post- transplantation cyclophosphamide, and prophylactic donor lymphocyte infusion There will be 2 cohorts of recipient participants: one with HLA-matched-related donors and one with HLA-haploidentical donors For HLA-matched HCT, the study will proceed to a small, three-level [1) DLI: 1 x 10^6 CD3+ cells/kg on day +7, 2) DLI: 3 x 10^6 CD3+ cells/kg on day +7, 3) DLI: 1 x 10^7 CD3+ cells/kg on day +7] phase I dose escalation study based on the standard 3+3 approach For HLA-haploidentical HCT, the study will proceed to a small, three-level [1) DLI: 1 x 10^5 CD3+ cells/kg on day +7, 2) DLI: 3 x 10^5 CD3+ cells/kg on day +7, 3) DLI: 1 x 10^6 CD3+ cells/kg on day +7] phase I dose escalation study based on the standard 3+3 approach Recipient participants will be evaluated for development of steroid-refractory grade III- IV acute GVHD (aGVHD) at day +60 as the dose-limiting toxicity. Phase II will proceed with DLI at the dose level (separately determined for each HLA cohort) which is associated with 0-1 of 6 recipient participants with steroid refractory grade III-IV aGVHD at day +60 and the least amount of toxicity. Simon optimal two-stage phase II trial design, to rule out excess steroid refractory grade III-IV aGVHD with the addition of prophylactic DLI, will be used in the phase II portion of the study which will enroll an additional 14 evaluable subjects in each cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms
Keywords
Prophylactic Donor Lymphocyte Infusions, Chronic Graft-Versus-Host Disease, Immunotherapeutic Strategies, myeloablative conditioning, Steroid-Refractory Grade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donor Arm
Arm Type
No Intervention
Arm Description
Donors for Recipients in Arms 1-4
Arm Title
Phase I Dose Escalation, Cohort 1 (matched)
Arm Type
Experimental
Arm Description
DLI at escalating doses (1 x 10^6 CD3+ cells/kg, 3 x 10^6 CD3+ cells/kg, and 1 x 10^7 CD3+ cells/kg) on day +7 or +21 to assess for safety and determine Phase II dose (up to 18 evaluable patients)
Arm Title
Phase I Dose Escalation, Cohort 2 (haploidentical)
Arm Type
Experimental
Arm Description
DLI at escalating doses (1 x 10^5 CD3+ cells/kg, 3 x 10^5 CD3+ cells/kg, and 1 x 10^6 CD3+ cells/kg) on day +7 or +21 to assess for safety and determine Phase II dose (up to 18 evaluable patients)
Arm Title
Phase II Efficacy, Cohort 1 (matched)
Arm Type
Experimental
Arm Description
DLI at maximally tolerated, safe dose (from Phase I) to assess secondary clinical outcomes at this dosing level (up to 14 additional evaluable patients in each cohort)
Arm Title
Phase II Efficacy, Cohort 2 (haploidentical)
Arm Type
Experimental
Arm Description
DLI at maximally tolerated, safe dose (from Phase I) to assess secondary clinical outcomes at this dosing level (up to 14 additional evaluable patients in each cohort)
Intervention Type
Procedure
Intervention Name(s)
donor lymphocyte infusion
Intervention Description
The DLI will be given on Day +7 (Day +21 for dose level -1). If a recipient participant is deemed too critically ill/unstable to receive DLI on the protocol specified day, the DLI will be delayed up to 4 days at the discretion of the PI and given within this time frame once the recipient participant s clinical status has stabilized or improved. If the DLI cannot be given during this time frame, the recipient participant will be taken off study and not considered evaluable for DLT, outcomes, or adverse events since the experimental intervention will not have been given.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
HLA-matched: 50 mg/kg IV once daily over 2 hours on days +3 and +4a Cyclophosphamide will be dosed according to ideal body weight. HLA haploidentical: 25 mg/kg IV once daily over 2 hours on days +3 and +4a Cyclophosphamide will be dosed according to ideal body weight.
Intervention Type
Drug
Intervention Name(s)
Busulfan
Intervention Description
AUC targeted dose based on busulfan test dose, with a default dose of 130 mg/m2/day, given as IV infusion over 3 hours each day for 4 days Transplant days -6 through day -3
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Intervention Description
15 mg/kg orally or IV three times daily (max 1000 mg/dose) starting on day +5, continued through day +35. Dosing will be according to actual body weight.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
40 mg/m2 IV infusion over 30-60 minutes once daily for 4 days Transplant days -6 through -3
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Intervention Description
Loading dose of 6 mg orally given on day +5 (calculated based on actual body weight, maximum initial dose 6 mg), then maintenance dose starting at 2 mg orally daily on day +6 with dose adjustments to maintain a trough of 5-12 ng/ml, continued through day +70 with no taper. Doses should be modified as appropriate for drug interactions.
Primary Outcome Measure Information:
Title
determine the maximally tolerated dose of DLI that can be safely administered after HLA-matched-related HCT and after HLA-haploidentical HCT
Description
fraction of evaluable patients who experience steroid-refractory grade III-IV aGVHD at day +60 will be determined and reported along with 80% and 95% two-sided confidence intervals.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of Steroid-refractory Grades II-IV and Grades III-IV aGVHD at days +100 and +200 for HLA-matched-related and HLA-haploidentical
Description
To evaluate steroid-refractory grade II-IV and grade III-IV acute GVHD at day 100 and 200.
Time Frame
Day 100 and 200
Title
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of chronic GVHD at 1 year for HLA-matched-related and HLA-haploidentical
Description
To evaluate chronic GVHD
Time Frame
1 year
Title
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of Grades II-IV and Grades III-IV aGVHD at days +100 and +200 for HLA-matched-related and HLA-haploidentical
Description
To evaluate grade II-IV and grade III-IV acute GVHD at day 100 and 200.
Time Frame
Day 100 and 200
Title
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of non-relapse mortality at 100 days and 1 year for HLA-matched-related and HLA-haploidentical
Description
To evaluate non-relapse mortality
Time Frame
Day 100 and 1 year
Title
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of relapse at 1 year for HLA-matched-related and HLA-haploidentical
Description
To evaluate relapse
Time Frame
1 year
Title
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of overall survival (OS) and disease-free survival (DFS) at 1 year for HLA-matched-related and HLA-haploidentical
Description
To evaluate survival
Time Frame
1 year
Title
determine, at the maximally tolerated dose in the phase II portion of the study, the cumulative incidences of primary engraftment (including time to neutrophil and platelet engraftment) for HLA-matched-related and HLA-haploidentical
Description
Rate and timing of neutrophil and platelet engraftment reported as median engraftment times for each and cumulative incidences of each at days +28 and +100
Time Frame
Day 28 and 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Inclusion Criteria - Recipient Histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk by the Refined Disease Risk Index for HCT including one of the following: Acute myeloid leukemia (AML) with favorable cytogenetics (t(8;21), inv(16), t(15,17)) with induction failure (persistent disease without first achieving remission of any type) or active relapse AML with intermediate cytogenetics (not classified as favorable or adverse) with induction failure or active relapse (AML with intermediate cytogenetics in morphologic complete remission [CR] with minimal residual disease detectable by any modality also will be eligible) AML with adverse cytogenetics (complex karyotype with >= 4 abnormalities) regardless of remission status Low risk myelodysplastic syndrome (MDS) (<= 5% blasts, including chronic myelomonocytic leukemia) with adverse cytogenetics (abnormal chromosome 7 or >= 4 abnormalities) with induction failure or active relapse High risk MDS (RAEB-1 or RAEB-2) with intermediate-risk cytogenetics (no abnormal chromosome 7 or < 4 abnormalities) with induction failure or active relapse High risk MDS (RAEB-1 or RAEB-2) with adverse cytogenetics (abnormal chromosome 7 or >= 4 abnormalities) regardless of remission status Acute lymphoblastic leukemia (ALL) in CR >= 2 or with induction failure or active relapse (ALL in CR1 with minimal residual disease detected also will be eligible) Chronic myelocytic leukemia (CML) in blast crisis phase Hodgkin lymphoma with stable or progressive disease Mantle cell lymphoma with stable or progressive disease Relapsed Burkitt lymphoma in CR or partial remission (PR) Aggressive B-cell Non-Hodgkin Lymphoma (NHL) (e.g., diffuse large B-cell lymphoma, transformed indolent B-cell lymphoma) with stable or progressive disease T-cell NHL with stable or progressive disease Multiple myeloma (MM) with induction failure as defined by failure to achieve minimal response (CR, Very Good Partial Response [VGPR], or PR) or the development of progressive disease on primary therapy, or MM with active relapse as defined by previously treated myeloma that achieved a molecular response or better that then progressed Age 18-65 years. At least one potentially suitable HLA-haploidentical or HLA-matched donor Karnofsky performance score >=60% Recipient participants must have adequate organ function as defined below: Cardiac ejection fraction >=45% by 2D ECHO; Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of >=50% predicted; Estimated serum creatinine clearance of >=60 ml/minute/1.73m2 calculated using eGFR in the clinical lab; Total bilirubin <=2X the upper limit of normal; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3X the upper limit of normal. Myeloablative conditioning is toxic to the developing human fetus and is teratogenic. For this reason, the following measures apply: Women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one-year post-transplant. WOCBP must have a negative serum or urine pregnancy test within 7 days prior to enrollment. Inclusion Criteria - Donor -Related donor (age >=12) deemed suitable, eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood, bone marrow, and stool for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation. EXCLUSION CRITERIA: Exclusion Criteria - Recipient Subjects who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 3 weeks prior to the date of beginning conditioning. Prior myeloablative conditioning for autologous or allogeneic HCT. Active breastfeeding. Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is metastatic, relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment. This excludes non-melanoma skin cancers. Uncontrolled intercurrent illness (e.g. severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active hepatitis, uncontrolled dental infection) that in the opinion of the PI would make it unsafe to proceed with transplantation. Exclusion Criteria - Donor None.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy H Chai
Phone
(301) 219-7105
Email
amy.chai@nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher G Kanakry, M.D.
Phone
(240) 760-6171
Email
christopher.kanakry@nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher G Kanakry, M.D.
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone
888-624-1937

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
.All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP
IPD Sharing Time Frame
Clinical data available during the study and indefinitely.@@@@@@@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
IPD Sharing Access Criteria
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_000489-C.html
Description
NIH Clinical Center Detailed Web Page

Learn more about this trial

Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies

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