Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Institut Paoli-Calmettes
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00740467
First received: August 22, 2008
Last updated: January 27, 2010
Last verified: July 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition |
Biological: anti-thymocyte globulin Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Leukemia
Lymphoma
Multiple Myeloma
Drug Information available for:
Cyclophosphamide
Busulfan
Fludarabine
Mycophenolic acid
Mycophenolate sodium
Cyclosporine
Fludarabine phosphate
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
Antilymphocyte Serum
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Incidence of graft acceptance [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740467
Locations
| France | |
| Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Recruiting |
| Marseille, France, 13273 | |
| Contact: Contact Person 33-4-91-22-37-54 | |
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
| Study Chair: | Didier Blaise, MD | Institut Paoli-Calmettes |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00740467 History of Changes |
| Other Study ID Numbers: | CDR0000592923, IPC-ITT-06-01, INCA-RECF0627, EUDRACT-2006-001369-14 |
| Study First Received: | August 22, 2008 |
| Last Updated: | January 27, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Neoplasms Graft vs Host Disease Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Precancerous Conditions Immune System Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Antilymphocyte Serum Busulfan Cyclophosphamide Cyclosporins Cyclosporine Mycophenolate mofetil Fludarabine monophosphate Fludarabine Mycophenolic Acid Vidarabine |
ClinicalTrials.gov processed this record on May 16, 2013