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Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer

Primary Purpose

Leukemia, Lymphoma, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
busulfan
cyclophosphamide
fludarabine phosphate
mycophenolate mofetil
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
Sponsored by
Northside Hospital, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II mantle cell lymphoma, accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, recurrent adult acute myeloid leukemia, refractory chronic lymphocytic leukemia, relapsing chronic myelogenous leukemia, secondary acute myeloid leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, prolymphocytic leukemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following high-risk hematologic malignancies:

    • Chronic myelogenous leukemia meeting one of the following criteria:

      • Disease in chronic phase and resistant to available tyrosine kinase inhibitors
      • Disease in accelerated phase
      • Disease with blast crisis that has entered into a second chronic phase after induction chemotherapy

    • Acute myelogenous leukemia meeting the following criteria:

      • Marrow blasts < 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH

      • Must meet one of the following criteria:

        • Disease in second or subsequent complete remission
        • Primary induction chemotherapy failure with disease subsequently entering complete remission
        • Disease in first complete remission with poor-risk cytogenetics or arising from preceding hematological disease

    • Myelodysplastic syndrome meeting at least one of the following criteria:

      • Treatment-related
      • Monosomy 7 or complex cytogenetics
      • International prognostic scoring system score ≥ 1.5
      • Chronic myelomonocytic leukemia

    • Acute lymphocytic leukemia or lymphoblastic lymphoma meeting the following criteria:

      • Marrow blasts < 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH

      • Must meet one of the following criteria:

        • Disease in second or subsequent complete remission
        • Acute lymphocytic leukemia with poor-risk karyotype [e.g., t(9;22) or bcr-abl fusion, t(4;11), or other MLL translocation] and in first complete remission

    • Chronic lymphocytic leukemia or prolymphocytic leukemia meeting both of the following criteria:

      • Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs
      • In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy)

    • Hodgkin or non-Hodgkin lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse disease) meeting the following criteria:

      • Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation
      • In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy) NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
  • No available matched related or unrelated donor OR a matched related or unrelated donor will not be available in the time frame necessary to perform a transplant

  • Availability of a first-degree relative (parent, child, sibling) matched at 3/6-5/6 loci (HLA-A, -B, -DR)

    • Donor must be willing to donate mobilized peripheral blood stem cells
    • No positive HLA crossmatch in the host-vs-graft direction or high titer donor-specific antibodies

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Bilirubin < 2 mg/dL (unless due to hemolysis, Gilbert syndrome, or primary malignancy)
  • Creatinine < 2 mg/dL OR creatinine clearance ≥ 40 mL/min
  • Not pregnant
  • Fertile patients must use effective contraception
  • LVEF (Left ventriculr ejection fraction) ≥ 45%
  • FEV_1 and forced vital capacity ≥ 50% predicted
  • No HIV positivity
  • No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No immunosuppressive agents ≤ 24 hours after completion of post-transplant cyclophosphamide (including steroids as antiemetics)

Sites / Locations

  • Blood and Marrow Transplant Group of Georgia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Myeloablative Haploidentical Transplant

Arm Description

All patients will receive treatment using Fludarabine, Busulfan and Cyclophosphamide prior to receiving a haploidentical transplant followed by post-transplant cyclosphosphamide.

Outcomes

Primary Outcome Measures

Incidence of Graft Rejection for Patients at Day 100
Number of patients who experienced graft rejection by Day 100
Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)
Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence

Secondary Outcome Measures

Overall Survival at Day 100
Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.
Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)
Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation
Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Overall Survival at 12 Months
Overall survival, defined as a patient being alive after transplant, is without regard to disease status.
Disease Free Survival at 12 Months
Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.
Disease Free Survival at Day 100
Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.

Full Information

First Posted
October 29, 2008
Last Updated
October 28, 2013
Sponsor
Northside Hospital, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00782379
Brief Title
Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer
Official Title
A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northside Hospital, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.
Detailed Description
OBJECTIVES: Primary To estimate the incidence of graft rejection and severe graft-versus-host disease after myeloablative HLA-mismatched peripheral blood stem cell transplantation (PBSCT) from first-degree relatives in patients with high-risk hematologic malignancies. Secondary To estimate overall survival, relapse, non-relapse mortality, and event-free survival in these patients. To characterize additional hematologic and non-hematologic toxicities of myeloablative haploidentical PBSCT. To characterize donor hematopoietic chimerism in peripheral blood stem cells after PBSCT. OUTLINE: Preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -2, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV over 1-2 hours on days -3 and -2. Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo infusion of unmanipulated peripheral blood stem cells on day 0. Post-transplant regimen: Patients receive high-dose cyclophosphamide IV over 1-2 hours on days 3 and 4, tacrolimus IV over 24 hours or orally twice daily on days 5-180, and oral mycophenolate mofetil 3 times daily on days 5-34 followed by a taper to day 90. Treatment continues in the absence of disease progression or clinically significant graft-vs-host disease. After completion of PBSCT, patients are followed periodically for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Myelodysplastic Syndromes
Keywords
stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II mantle cell lymphoma, accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, recurrent adult acute myeloid leukemia, refractory chronic lymphocytic leukemia, relapsing chronic myelogenous leukemia, secondary acute myeloid leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, prolymphocytic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myeloablative Haploidentical Transplant
Arm Type
Experimental
Arm Description
All patients will receive treatment using Fludarabine, Busulfan and Cyclophosphamide prior to receiving a haploidentical transplant followed by post-transplant cyclosphosphamide.
Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Description
110 mg/m2 infused over 3 hours once daily on 4 consecutive days (Days -7, -6, -5, -4)
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
14.5 mg/kg infused over 1-2 hours once daily on 2 consecutive days (days -3,-2).
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Description
30mg/m2 infused over 30 minutes once daily on three consecutive days (days -5, -4, -3)
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Other Intervention Name(s)
CellCept
Intervention Description
15 mg/kg po three times a daily with a maximum dose of 3gm/day starting D+5. To be discontinued on Day +35 in the absence of clinically significant GVHD.
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
Prograf, FK-506
Intervention Description
0.03 mg/kg/day infuse over 24 hours starting on day +5 (adjusted to maintain trough level of 5-15 ng/ml). Switch to oral (twice daily divided dose) on day +21 or when able to tolerate PO. Discontinue on day +180 in the absence of clinically significant GVHD.
Intervention Type
Procedure
Intervention Name(s)
allogeneic hematopoietic stem cell transplantation
Other Intervention Name(s)
Allo HSCT
Intervention Description
Patients to received unmanipulated PBSCs on Day 0
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Other Intervention Name(s)
allogeneic hematopoietic stem cell transplant
Intervention Description
patients to receive unmanipulated PBSCs on day 0
Primary Outcome Measure Information:
Title
Incidence of Graft Rejection for Patients at Day 100
Description
Number of patients who experienced graft rejection by Day 100
Time Frame
Day 100
Title
Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)
Description
Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence
Time Frame
Day 100
Secondary Outcome Measure Information:
Title
Overall Survival at Day 100
Description
Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.
Time Frame
Day 100
Title
Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)
Description
Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.
Time Frame
1 year
Title
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation
Description
Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Time Frame
Day 30
Title
Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)
Time Frame
Day 100
Title
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation
Description
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Time Frame
Day 60
Title
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation
Description
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Time Frame
Day 90
Title
Overall Survival at 12 Months
Description
Overall survival, defined as a patient being alive after transplant, is without regard to disease status.
Time Frame
12 months
Title
Disease Free Survival at 12 Months
Description
Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.
Time Frame
12 months
Title
Disease Free Survival at Day 100
Description
Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.
Time Frame
Day 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of one of the following high-risk hematologic malignancies: Chronic myelogenous leukemia meeting one of the following criteria: Disease in chronic phase and resistant to available tyrosine kinase inhibitors Disease in accelerated phase Disease with blast crisis that has entered into a second chronic phase after induction chemotherapy Acute myelogenous leukemia meeting the following criteria: Marrow blasts < 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH Must meet one of the following criteria: Disease in second or subsequent complete remission Primary induction chemotherapy failure with disease subsequently entering complete remission Disease in first complete remission with poor-risk cytogenetics or arising from preceding hematological disease Myelodysplastic syndrome meeting at least one of the following criteria: Treatment-related Monosomy 7 or complex cytogenetics International prognostic scoring system score ≥ 1.5 Chronic myelomonocytic leukemia Acute lymphocytic leukemia or lymphoblastic lymphoma meeting the following criteria: Marrow blasts < 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH Must meet one of the following criteria: Disease in second or subsequent complete remission Acute lymphocytic leukemia with poor-risk karyotype [e.g., t(9;22) or bcr-abl fusion, t(4;11), or other MLL translocation] and in first complete remission Chronic lymphocytic leukemia or prolymphocytic leukemia meeting both of the following criteria: Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy) Hodgkin or non-Hodgkin lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse disease) meeting the following criteria: Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy) NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. No available matched related or unrelated donor OR a matched related or unrelated donor will not be available in the time frame necessary to perform a transplant Availability of a first-degree relative (parent, child, sibling) matched at 3/6-5/6 loci (HLA-A, -B, -DR) Donor must be willing to donate mobilized peripheral blood stem cells No positive HLA crossmatch in the host-vs-graft direction or high titer donor-specific antibodies PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Bilirubin < 2 mg/dL (unless due to hemolysis, Gilbert syndrome, or primary malignancy) Creatinine < 2 mg/dL OR creatinine clearance ≥ 40 mL/min Not pregnant Fertile patients must use effective contraception LVEF (Left ventriculr ejection fraction) ≥ 45% FEV_1 and forced vital capacity ≥ 50% predicted No HIV positivity No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up PRIOR CONCURRENT THERAPY: See Disease Characteristics No immunosuppressive agents ≤ 24 hours after completion of post-transplant cyclophosphamide (including steroids as antiemetics)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott R. Solomon, MD
Organizational Affiliation
Blood and Marrow Transplant Group of Georgia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
H. Kent Holland, MD
Organizational Affiliation
Blood and Marrow Transplant Group of Georgia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asad Bashey, MD, PhD
Organizational Affiliation
Blood and Marrow Transplant Group of Georgia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence E. Morris, MD
Organizational Affiliation
Blood and Marrow Transplant Group of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blood and Marrow Transplant Group of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer

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