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TMLI and Alemtuzumab for Treatment of Sickle Cell Disease

Primary Purpose

Sickle Cell Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alemtuzumab
Hematopoietic Cell Transplantation
Intensity-Modulated Radiation Therapy
Sirolimus
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Documented informed consent of the participant and/or legally authorized representative

    • Assent, when appropriate, will be obtained per institutional guidelines
  • Registered into Risk Evaluation and Mitigation Strategies (REMS) program
  • Age: 2-40 years
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Have a diagnosis of sickle cell disease, be at a high risk for disease related morbidity or mortality, which must be defined by one of the following disease status criteria:

    • Significant neurologic event (stroke) or any neurological deficit lasting > 24 hours; or increased transcranial Doppler velocity (> 200 m/s).
    • History of one or more episodes of acute chest syndrome (ACS) in the 2-year period preceding enrollment despite the institution of supportive care measures (i.e. asthma therapy and/or hydroxyurea).
    • History of one or more severe vaso-occlusive pain crises per year in the 2-year period preceding enrollment despite the institution of supportive care measures (i.e. a pain management plan and/or treatment with hydroxyurea).
    • Recurrent priapism requiring medical therapy.
    • Osteonecrosis of two or more joints despite the institution of supportive care measures.
    • Prior treatment with regular red blood cell (RBC) transfusion therapy, defined as receiving 8 or more transfusions per year for > 1 year to prevent vaso-occlusive clinical complications (i.e. pain, stroke, and acute chest syndrome)
    • Echocardiograph finding of tricuspid valve regurgitation jet (TRJ) velocity >= 2.5 m/sec.
  • Have a related donor who is matched on at least 8/10 human leukocyte antigen (HLA)-A, B, C, and DRB1 Loci
  • Total bilirubin =< 2.5 x upper limit normal (ULN( (unless has Gilbert's disease) (performed within 30 days prior to day 1 of protocol)
  • Aspartate aminotransferase (AST) =< 1.5 x ULN (performed within 30 days prior to day 1 of protocol)
  • Alanine aminotransferase (ALT) =< 1.5 x ULN (performed within 30 days prior to day 1 of protocol)
  • Creatinine clearance (CrCl) of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 30 days prior to day 1 of protocol)
  • If not receiving anticoagulants: International Normalized Ratio (INR) OR Prothrombin (PT) =< 1.5 x ULN (performed within 30 days prior to day 1 of protocol)

    • If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants
  • If not receiving anticoagulants: Activated Partial Thromboplastin Time (aPTT) =<1.5 x ULN (performed within 30 days prior to day 1 of protocol)

    • If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants
  • Left ventricular ejection fraction (LVEF) >= 50% (performed within 30 days prior to day 1 of protocol)

    • Note: To be performed within 28 days prior to Day 1 of protocol therapy.
  • If able to perform pulmonary function tests: Forced expiratory volume in 1 second (FEV1), force vital capacity (FVC), and diffused lung capacity of carbon monoxide (DLCO) (diffusion capacity) >= 50% of predicted (corrected for hemoglobin)

    • If unable to perform pulmonary function tests: Oxygen (O 2) saturation > 92% on room air
    • Note: To be performed within 28 days prior to Day 1 of protocol therapy.
  • Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma regain [RPR])

    • If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed
  • Meets other institutional and federal requirements for infectious disease titer requirements

    • Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test

    • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be require.
  • Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least Six months after the last dose of protocol therapy.

    • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
  • DONOR: Age =< 60 years
  • DONOR: Medical history and physical examination confirm good health status as defined by institutional standards
  • DONOR: Serologies for: Hepatitis B (HBV) Core Antibody, HIV I/II Antibody, human T-lymphotropic virus (HTLV) - I/II antibody, HCV antibody, Hepatitis B surface antigen, Serologic Test for Syphilis, HIV-1/HCV/HBV nucleic acid, West Nile virus nucleic acid, Trypanosoma cruzi antibody, Cytomegalovirus (CMV) antibody, (AKA: Donor Room Serologies)
  • DONOR: Female donors of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (b-HCG) test within 30 days of initiation of conditioning, 30 days of patients admission for conditioning and 7 days of mobilization or bone marrow harvest.
  • DONOR: The donor must be informed of the investigational nature of this study and have signed a consent form in accordance with Federal Guidelines and the guidelines of the participating institution

Exclusion Criteria:

  • Prior allogeneic or autologous stem cell transplant
  • Patients who are receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.
  • History of allergic reactions attributable to compounds of similar chemical or biologic composition to study agent
  • Patients with any active malignancy are ineligible for this study, other than non-melanoma skin cancers
  • Medical problem or neurologic/psychiatric dysfunction which would impair patient ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the principal investigator would place the recipient at unacceptable risk.
  • Active infection requiring antibiotics
  • Females only: Pregnant or breastfeeding
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
  • DONOR: Evidence of active infection
  • DONOR: Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis if donating peripheral stem cells or unlikely to tolerate general anesthesia and bone marrow collection if donating a bone marrow
  • DONOR: Factors which place the donor at increased risk for complications from leukapheresis or granulocyte colony-stimulating Factor (G-CSF) therapy if donating peripheral stem cells or general anesthesia and bone marrow collection if donating a bone marrow
  • DONOR: Lactating female or, if of child-bearing potential, is unwilling to implement adequate birth control
  • DONOR: HIV positive
  • DONOR: Prior radiation therapy

Sites / Locations

  • City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (TMLI, alemtuzumab)

Arm Description

Patients receive alemtuzumab IV over 4 hours QD on days -7 to -3. Patients undergo TMLI BID on day -2. Patients also undergo HCT on day 0 and receive sirolimus on day -1 and day 0.

Outcomes

Primary Outcome Measures

Incidence of adverse events
Will be scored on the Bearman Scale National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with the unacceptable adverse events will be calculated along with the appropriate Clopper-Pearson 90% confidence intervals.
Feasibility
Feasibility will be defined as engraftment that would be sufficient to reduce sickle cell disease (SCD) burden (Any donor chimerism with Hgb S =< 30%).

Secondary Outcome Measures

Platelet engraftment
Platelet engraftment will be defined as independence from platelet transfusion for at least 7 days with a platelet count of more than >20 × 10^9/L
Time to acute graft-versus-host disease (grades 2-4 and 3-4) until day +100 after transplant
Acute Graft versus Host Disease (aGVHD) of grades 2-4 and 3-4: Documented/biopsy proven acute graft versus host disease is graded according to the Consensus Grading. Time to event is measured from date of stem cell infusion to document/biopsy proven acute GVHD onset date (within the first 100 days post-transplant) and will be used to estimate the cumulative incidence.
Time to chronic graft-versus-host disease for up to one year after transplant
Chronic Graft versus Host Disease (cGVHD): chronic Graft versus Host Disease (aGVHD) of grades 2-4 and 3-4: Documented/biopsy proven chronic graft versus host disease is scored according to NIH Consensus Staging. Time to event is measured from date of stem cell infusion to the documented/biopsy proven chronic GVHD onset date and will be used to estimate the cumulative incidence.
Overall survival (OS)
Patients are considered a failure for this endpoint if they die, regardless of cause.
Event-free survival (EFS)
Patients are considered a failure for this endpoint if they graft failure, or die, regardless of cause. Time to this event is the time from start of protocol therapy to death, graft failure, or last follow-up, whichever comes first.
Disease-free Survival (DFS)
Patients are considered a failure for this endpoint if they die (regardless of cause) or experience disease progression or relapse.

Full Information

First Posted
May 3, 2022
Last Updated
June 14, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05384756
Brief Title
TMLI and Alemtuzumab for Treatment of Sickle Cell Disease
Official Title
A Pilot Study of Nonmyeloablative Regimen Using Total Marrow and Lymphoid Irradiation for Irradiation Sparing of Bystander Organs in Hematopoietic Cell Transplantation From Matched Related or Unrelated Donor in Patients With Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
October 26, 2028 (Anticipated)
Study Completion Date
October 26, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

Brief Summary
This phase I trial tests the safety and effectiveness of total marrow and lymphoid irradiation (TMLI) and alemtuzumab as a conditioning regimen in patients with sickle cell disease. Conditioning regimens are treatments used to prepare a patient for stem cell transplantation. A stem cell transplant is a procedure in which a person receives blood stem cells, which make any type of blood cell. A conditioning regimen may include chemotherapy, monoclonal antibody therapy, and radiation to the entire body. It helps make room in the patient's bone marrow for new blood stem cells to grow, and helps prevent the patient's body from rejecting the transplanted cells. Alemtuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Graft-versus-host disease (GVHD) is a complication that may occur after hematopoietic cell transplantation (HCT) in which donated cells view the recipient's cells as foreign and attack them. Giving TMLI and alemtuzumab may help reduce organ damage that can be caused by radiation and decrease the risk of GVHD.
Detailed Description
PRIMARY OBJECTIVE: I. Evaluate the safety and feasibility of a fixed TMLI dose of 600 cGy with alemtuzumab as non-myeloablative conditioning (NMC) regimen in patients with sickle cell disease to achieve stable engraftment by Day +100 post HCT. SECONDARY OBJECTIVES: I. Assess the hematopoietic recovery by determining donor neutrophil engraftment, platelet engraftment. II. Assess irradiation doses to non-target organs (lungs, heart, liver, spleen, kidneys, and gonads). III. Assess the incidence of acute GvHD (grade II - IV) during the first 100 days after transplantation and chronic GvHD at 1 year post-HCT. IV. Assess overall, event-free, and disease free survival at 1 year post-HCT. V. Assess donor chimerism at day +100 and 1 and 2 years after HCT. EXPLORATORY OBJECTIVES: I. Assess immune reconstitution post HCT on baseline, then on days +15, +30, +60, and +180, and 1-year post-HCT. II. Assessment of quality of life at baseline, Day+100, Day +180 and at 1-year post-HCT. III. Define the impact of sickle cell disease (SCD) including inflammation on the bone marrow microenvironment and hematopoietic cells function at baseline. IV. Monitor treatment response noninvasively on the recovery of bone marrow microenvironment (hematopoietic and vascular). V. Monitor treatment response noninvasively on cerebral blood flow (CBF). OUTLINE: Patients receive alemtuzumab intravenously (IV) over 4 hours once daily (QD) on days -7 to -3. Patients undergo TMLI twice daily (BID) on day -2. Patients also undergo HCT on day 0 and receive sirolimus on day -1 and day 0. After study treatment, patients are followed up on day 30, and for up to 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (TMLI, alemtuzumab)
Arm Type
Experimental
Arm Description
Patients receive alemtuzumab IV over 4 hours QD on days -7 to -3. Patients undergo TMLI BID on day -2. Patients also undergo HCT on day 0 and receive sirolimus on day -1 and day 0.
Intervention Type
Drug
Intervention Name(s)
Alemtuzumab
Other Intervention Name(s)
Anti-CD52 Monoclonal Antibody, Campath, Campath-1H, LDP-03, Lemtrada, MabCampath, Monoclonal Antibody Campath-1H
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic Cell Transplantation
Other Intervention Name(s)
HCT, Hematopoietic Stem Cell Infusion, Hematopoietic Stem Cell Transplantation, HSCT, Stem Cell Transplant, stem cell transplantation
Intervention Description
Undergo HCT
Intervention Type
Radiation
Intervention Name(s)
Intensity-Modulated Radiation Therapy
Other Intervention Name(s)
IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Intervention Description
Undergo TMLI
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
AY 22989, RAPA, Rapamune, Rapamycin, SILA 9268A, WY-090217
Intervention Description
Medication to prevent the development of graft-versus-host disease (GVHD)
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Will be scored on the Bearman Scale National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients with the unacceptable adverse events will be calculated along with the appropriate Clopper-Pearson 90% confidence intervals.
Time Frame
Up to day 100 post-transplant
Title
Feasibility
Description
Feasibility will be defined as engraftment that would be sufficient to reduce sickle cell disease (SCD) burden (Any donor chimerism with Hgb S =< 30%).
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Platelet engraftment
Description
Platelet engraftment will be defined as independence from platelet transfusion for at least 7 days with a platelet count of more than >20 × 10^9/L
Time Frame
Up to 2 years
Title
Time to acute graft-versus-host disease (grades 2-4 and 3-4) until day +100 after transplant
Description
Acute Graft versus Host Disease (aGVHD) of grades 2-4 and 3-4: Documented/biopsy proven acute graft versus host disease is graded according to the Consensus Grading. Time to event is measured from date of stem cell infusion to document/biopsy proven acute GVHD onset date (within the first 100 days post-transplant) and will be used to estimate the cumulative incidence.
Time Frame
Up to 2 years
Title
Time to chronic graft-versus-host disease for up to one year after transplant
Description
Chronic Graft versus Host Disease (cGVHD): chronic Graft versus Host Disease (aGVHD) of grades 2-4 and 3-4: Documented/biopsy proven chronic graft versus host disease is scored according to NIH Consensus Staging. Time to event is measured from date of stem cell infusion to the documented/biopsy proven chronic GVHD onset date and will be used to estimate the cumulative incidence.
Time Frame
Up to 2 years
Title
Overall survival (OS)
Description
Patients are considered a failure for this endpoint if they die, regardless of cause.
Time Frame
From start of protocol therapy to death, or last follow-up, whichever comes first, assessed up to 2 years
Title
Event-free survival (EFS)
Description
Patients are considered a failure for this endpoint if they graft failure, or die, regardless of cause. Time to this event is the time from start of protocol therapy to death, graft failure, or last follow-up, whichever comes first.
Time Frame
From start of protocol therapy to death, graft failure, or last follow-up, whichever comes first, assessed up to 2 years
Title
Disease-free Survival (DFS)
Description
Patients are considered a failure for this endpoint if they die (regardless of cause) or experience disease progression or relapse.
Time Frame
From date of stem cell infusion to death, disease relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years
Other Pre-specified Outcome Measures:
Title
Immune cell reconstitution
Description
Immune cell reconstitution will be assessed by flow cytometry analysis
Time Frame
Up to 2 years
Title
Quality of life - PedsQL
Description
Items on the PedsQL Generic Core Scales are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life: 0 ("Never") = 100 ("Almost Never") = 75 ("Sometimes") = 50 ("Often") = 25 ("Almost Always") = 0 For adults 16-item QOLS patients will be given a copy of the 7-point response scale ["delighted" (7), "pleased" (6), "mostly satisfied" (5), "mixed" (4), "mostly dissatisfied" (3), "unhappy" (2), "terrible" (1).] The QOLS scores will be summed so that a higher score indicates higher quality of life. Average total score for healthy populations is about 90. However, like many QOL instruments, the means tend to be quite negatively skewed with most patients reporting some degree of satisfaction with most domains of their lives.
Time Frame
Up to 2 years
Title
Bone marrow environment inflation - levels of inflammatory cytokines
Description
The long-term impact of Sickle Cell Disease on patients bone marrow will be measured by evaluation of the levels of inflammatory cytokines in the bone marrow before treatment with TMLI and alemtuzumab.
Time Frame
Baseline only (pre-conditioning)
Title
Bone marrow environment inflation - stem cell function
Description
The long-term impact of Sickle Cell Disease on patients bone marrow will be measured by evaluation of the stem cell function in the bone marrow before treatment with TMLI and alemtuzumab.
Time Frame
Baseline only (pre-conditioning)
Title
Treatment response on bone marrow environment and CBF
Description
Treatment response on bone marrow environment and CBF will be assessed by Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). All imaging will be performed before the start of the treatment and post-transplant at days 30, 100, 180, and at one year, coinciding with time points when clinical standard biopsy samples are obtained.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Documented informed consent of the participant and/or legally authorized representative Assent, when appropriate, will be obtained per institutional guidelines Registered into Risk Evaluation and Mitigation Strategies (REMS) program Age: 2-40 years Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Have a diagnosis of sickle cell disease, be at a high risk for disease related morbidity or mortality, which must be defined by one of the following disease status criteria: Significant neurologic event (stroke) or any neurological deficit lasting > 24 hours; or increased transcranial Doppler velocity (> 200 m/s). History of one or more episodes of acute chest syndrome (ACS) in the 2-year period preceding enrollment despite the institution of supportive care measures (i.e. asthma therapy and/or hydroxyurea). History of one or more severe vaso-occlusive pain crises per year in the 2-year period preceding enrollment despite the institution of supportive care measures (i.e. a pain management plan and/or treatment with hydroxyurea). Recurrent priapism requiring medical therapy. Osteonecrosis of two or more joints despite the institution of supportive care measures. Prior treatment with regular red blood cell (RBC) transfusion therapy, defined as receiving 8 or more transfusions per year for > 1 year to prevent vaso-occlusive clinical complications (i.e. pain, stroke, and acute chest syndrome) Echocardiograph finding of tricuspid valve regurgitation jet (TRJ) velocity >= 2.5 m/sec. Have a related donor who is matched on at least 8/10 human leukocyte antigen (HLA)-A, B, C, and DRB1 Loci Total bilirubin =< 2.5 x upper limit normal (ULN( (unless has Gilbert's disease) (performed within 30 days prior to day 1 of protocol) Aspartate aminotransferase (AST) =< 1.5 x ULN (performed within 30 days prior to day 1 of protocol) Alanine aminotransferase (ALT) =< 1.5 x ULN (performed within 30 days prior to day 1 of protocol) Creatinine clearance (CrCl) of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 30 days prior to day 1 of protocol) If not receiving anticoagulants: International Normalized Ratio (INR) OR Prothrombin (PT) =< 1.5 x ULN (performed within 30 days prior to day 1 of protocol) If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants If not receiving anticoagulants: Activated Partial Thromboplastin Time (aPTT) =<1.5 x ULN (performed within 30 days prior to day 1 of protocol) If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants Left ventricular ejection fraction (LVEF) >= 50% (performed within 30 days prior to day 1 of protocol) Note: To be performed within 28 days prior to Day 1 of protocol therapy. If able to perform pulmonary function tests: Forced expiratory volume in 1 second (FEV1), force vital capacity (FVC), and diffused lung capacity of carbon monoxide (DLCO) (diffusion capacity) >= 50% of predicted (corrected for hemoglobin) If unable to perform pulmonary function tests: Oxygen (O 2) saturation > 92% on room air Note: To be performed within 28 days prior to Day 1 of protocol therapy. Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma regain [RPR]) If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed Meets other institutional and federal requirements for infectious disease titer requirements Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be require. Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least Six months after the last dose of protocol therapy. Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only) DONOR: Age =< 60 years DONOR: Medical history and physical examination confirm good health status as defined by institutional standards DONOR: Serologies for: Hepatitis B (HBV) Core Antibody, HIV I/II Antibody, human T-lymphotropic virus (HTLV) - I/II antibody, HCV antibody, Hepatitis B surface antigen, Serologic Test for Syphilis, HIV-1/HCV/HBV nucleic acid, West Nile virus nucleic acid, Trypanosoma cruzi antibody, Cytomegalovirus (CMV) antibody, (AKA: Donor Room Serologies) DONOR: Female donors of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (b-HCG) test within 30 days of initiation of conditioning, 30 days of patients admission for conditioning and 7 days of mobilization or bone marrow harvest. DONOR: The donor must be informed of the investigational nature of this study and have signed a consent form in accordance with Federal Guidelines and the guidelines of the participating institution Exclusion Criteria: Prior allogeneic or autologous stem cell transplant Patients who are receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy. History of allergic reactions attributable to compounds of similar chemical or biologic composition to study agent Patients with any active malignancy are ineligible for this study, other than non-melanoma skin cancers Medical problem or neurologic/psychiatric dysfunction which would impair patient ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the principal investigator would place the recipient at unacceptable risk. Active infection requiring antibiotics Females only: Pregnant or breastfeeding Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics) DONOR: Evidence of active infection DONOR: Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis if donating peripheral stem cells or unlikely to tolerate general anesthesia and bone marrow collection if donating a bone marrow DONOR: Factors which place the donor at increased risk for complications from leukapheresis or granulocyte colony-stimulating Factor (G-CSF) therapy if donating peripheral stem cells or general anesthesia and bone marrow collection if donating a bone marrow DONOR: Lactating female or, if of child-bearing potential, is unwilling to implement adequate birth control DONOR: HIV positive DONOR: Prior radiation therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Pawlowska
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Pawlowska
Phone
626-218-8442
Email
apawlowska@coh.org
First Name & Middle Initial & Last Name & Degree
Anna Pawlowska

12. IPD Sharing Statement

Learn more about this trial

TMLI and Alemtuzumab for Treatment of Sickle Cell Disease

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