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Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders

Primary Purpose

Graft Versus Host Disease, Leukemia, Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
anti-thymocyte globulin
busulfan
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring graft versus host disease, 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), recurrent adult acute myeloid leukemia, adult acute lymphoblastic leukemia in remission, recurrent adult acute lymphoblastic leukemia, accelerated phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, refractory multiple myeloma, relapsing chronic myelogenous leukemia, recurrent adult Hodgkin lymphoma, adult nasal type extranodal NK/T-cell lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade III lymphomatoid granulomatosis, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent grade I lymphomatoid granulomatosis, recurrent grade II lymphomatoid granulomatosis, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, refractory chronic lymphocytic leukemia

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Diagnosis of any of the following hematological cancers with a poor prognosis:

    • Acute myeloid leukemia meeting 1 of the following criteria:

      • Third complete remission (CR3) or beyond
      • CR2 after an early bone marrow relapse (< 24 months)
      • Refractory disease after ≥ 2 chemotherapy courses of induction therapy

    • Acute lymphoblastic leukemia meeting 1 of the following criteria:

      • CR3 after ≥ 1 bone marrow relapse
      • CR2 after early bone marrow relapse (currently or within 6 months after stopping maintenance therapy)

    • Chronic myelogenous leukemia meeting the following criteria:

      • Accelerated phase
      • Second chronic phase
      • No other treatment options

    • Multiple myeloma meeting the following criteria:

      • Failed conventional therapy (including autologous hematopoietic stem cell transplantation)
      • No other treatment alternatives

    • Chronic lymphocytic leukemia meeting the following criteria:

      • Failed conventional therapy
      • No other treatment alternatives

    • Hodgkin lymphoma meeting the following criteria:

      • Failed conventional therapy
      • No other treatment alternatives

    • Non-Hodgkin lymphoma meeting the following criteria:

      • Failed conventional therapy
      • No other treatment alternatives
  • Not eligible for standard myeloablative allograft due to increased toxicity

  • Healthy related donor available and meeting the following criteria:

    • Brother, sister, father, mother, cousin, uncle, or aunt

    • At least an identical HLA haplotype

      • Identical genotype on 1 haplotype (in terms of HLA-A, B, C, and DR)
      • Different on ≤ 4 alleles on the other haplotype
  • No HLA-identical intra- or extra-familial donor cord blood available within the next 3 months

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

  • No contraindication to allogeneic transplantation, including any of the following:

    • Cardiac systolic ejection fraction < 40%
    • DLCO level limiting use of fludarabine
    • Creatinine clearance < 30 mL/min
    • Transaminases and/or bilirubin > 3 times upper limit of normal (unless due to Gilbert disease or cancer)
    • HIV seropositivity
    • Human T-cell lymphotrophic virus type 1 seropositivity
    • Uncontrolled bacterial, viral, or fungal infection
  • No contraindication to any of the study drugs
  • No prior or concurrent psychiatric illness
  • No other cancer in the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix
  • No concurrent serious, uncontrolled condition
  • No patients deprived of liberty or subject to legal protection

PRIOR CONCURRENT THERAPY:

  • No participation in a study of allografts in the past month

Sites / Locations

  • Marseille Institute of Cancer - Institut J. Paoli and I. CalmettesRecruiting

Outcomes

Primary Outcome Measures

Incidence of graft acceptance

Secondary Outcome Measures

Full Information

First Posted
August 22, 2008
Last Updated
January 27, 2010
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT00740467
Brief Title
Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders
Official Title
Allograft of Hematopoietic Stem Cells With Reduced-intensity Conditioning From a HLA-haploidentical Family Donor: Phase II Study of Combined Immunosuppression Before and After Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, together with antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. Giving chemotherapy before or after transplant also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer and abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well stem cell transplant works in treating patients with hematological cancer or other disorders.
Detailed Description
OBJECTIVES: Primary Evaluate the incidence of graft acceptance in patients with hematological disorders treated with combined immunosuppression before and after HLA-haploidentical hematopoietic stem cell transplantation. Secondary Evaluate efficacy of this regimen in these patients. Evaluate toxicity of this regimen in these patients. Assess survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -6 to -1, busulfan IV on days -6 to -5, and anti-thymocyte globulin IV on days -4 to -1. Transplantation: Patients undergo transplantation of donor hematopoietic stem cells on day 0. Patients also receive cyclophosphamide IV on day 3 and filgrastim (G-CSF) beginning on day 4 and continuing until blood counts recover. Immunosuppression: Patients receive cyclosporine IV beginning on day -2 and continuing for 6 months and mycophenolate mofetil 4 times a day on days 4-84.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition
Keywords
graft versus host disease, 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), recurrent adult acute myeloid leukemia, adult acute lymphoblastic leukemia in remission, recurrent adult acute lymphoblastic leukemia, accelerated phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, refractory multiple myeloma, relapsing chronic myelogenous leukemia, recurrent adult Hodgkin lymphoma, adult nasal type extranodal NK/T-cell lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade III lymphomatoid granulomatosis, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent grade I lymphomatoid granulomatosis, recurrent grade II lymphomatoid granulomatosis, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, refractory chronic lymphocytic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
anti-thymocyte globulin
Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Intervention Type
Procedure
Intervention Name(s)
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Primary Outcome Measure Information:
Title
Incidence of graft acceptance

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 any of the following hematological cancers with a poor prognosis: Acute myeloid leukemia meeting 1 of the following criteria: Third complete remission (CR3) or beyond CR2 after an early bone marrow relapse (< 24 months) Refractory disease after ≥ 2 chemotherapy courses of induction therapy Acute lymphoblastic leukemia meeting 1 of the following criteria: CR3 after ≥ 1 bone marrow relapse CR2 after early bone marrow relapse (currently or within 6 months after stopping maintenance therapy) Chronic myelogenous leukemia meeting the following criteria: Accelerated phase Second chronic phase No other treatment options Multiple myeloma meeting the following criteria: Failed conventional therapy (including autologous hematopoietic stem cell transplantation) No other treatment alternatives Chronic lymphocytic leukemia meeting the following criteria: Failed conventional therapy No other treatment alternatives Hodgkin lymphoma meeting the following criteria: Failed conventional therapy No other treatment alternatives Non-Hodgkin lymphoma meeting the following criteria: Failed conventional therapy No other treatment alternatives Not eligible for standard myeloablative allograft due to increased toxicity Healthy related donor available and meeting the following criteria: Brother, sister, father, mother, cousin, uncle, or aunt At least an identical HLA haplotype Identical genotype on 1 haplotype (in terms of HLA-A, B, C, and DR) Different on ≤ 4 alleles on the other haplotype No HLA-identical intra- or extra-familial donor cord blood available within the next 3 months PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Not pregnant or nursing Fertile patients must use effective contraception No contraindication to allogeneic transplantation, including any of the following: Cardiac systolic ejection fraction < 40% DLCO level limiting use of fludarabine Creatinine clearance < 30 mL/min Transaminases and/or bilirubin > 3 times upper limit of normal (unless due to Gilbert disease or cancer) HIV seropositivity Human T-cell lymphotrophic virus type 1 seropositivity Uncontrolled bacterial, viral, or fungal infection No contraindication to any of the study drugs No prior or concurrent psychiatric illness No other cancer in the past 5 years except for basal cell skin cancer or carcinoma in situ of the cervix No concurrent serious, uncontrolled condition No patients deprived of liberty or subject to legal protection PRIOR CONCURRENT THERAPY: No participation in a study of allografts in the past month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Blaise, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Study Chair
Facility Information:
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
33-4-91-22-37-54

12. IPD Sharing Statement

Learn more about this trial

Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders

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