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

NCT ID: NCT00740467

Last Updated: 2010-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

anti-thymocyte globulin

Intervention Type: BIOLOGICAL

busulfan

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

cyclosporine

Intervention Type: DRUG

fludarabine phosphate

Intervention Type: DRUG

mycophenolate mofetil

Intervention Type: DRUG

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Principal Investigators

Didier Blaise, MD

Role: STUDY_CHAIR

Institut Paoli-Calmettes

Locations

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Contact Person

Role: primary

Other Identifiers

IPC-ITT-06-01

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0627

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2006-001369-14

Identifier Type: -

Identifier Source: secondary_id

CDR0000592923

Identifier Type: -

Identifier Source: org_study_id