Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant
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Purpose
RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose chemotherapy and autologous stem cell transplant .
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms |
Biological: anti-thymocyte globulin Biological: donor lymphocytes Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: busulfan Drug: fludarabine phosphate Drug: methotrexate Drug: mycophenolate mofetil Drug: tacrolimus Other: pharmacological study Other: reduced-intensity transplant conditioning procedure Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation as Second Transplantation for Patients With Disease Relapse or Myelodysplasia After Prior Autologous Transplantation |
- Event-free survival (EFS) [ Designated as safety issue: No ]
- Comparison of EFS distribution to that of CALGB-100002 [ Designated as safety issue: No ]
- Complete response rate [ Designated as safety issue: No ]
- Complete (> 90%) or mixed donor chimerism [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Rate of opportunistic infections [ Designated as safety issue: No ]
- Graft-versus-host disease at 6 months [ Designated as safety issue: No ]
| Estimated Enrollment: | 88 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed hematologic malignancies:
Chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL)
- Absolute lymphocytosis of > 5,000/μL
Lymphocytes must appear morphologically mature with < 55% prolymphocytes (CLL)
- Patients with > 55% prolymphocytes are considered as having PLL
- Lymphocyte phenotype with expression of CD20, CD19, and CD5 (CLL)
Non-Hodgkin lymphoma
- Any WHO classification of histologic subtype
- Core biopsies acceptable for primary diagnosis and immunophenotyping
- Bone marrow biopsies as sole means of diagnosis not allowed for follicular lymphoma
Hodgkin lymphoma
- Any WHO classification of histologic subtype
- Core biopsies acceptable for primary diagnosis and immunophenotyping
- Bone marrow biopsy is required
Multiple myeloma
- Patients must have active disease requiring treatment (Durie-Salmon stage I-III)
Acute myeloid leukemia
- Must have < 10% bone marrow blasts and no circulating blasts
Myelodysplastic syndrome (MDS)
- MDS as define by WHO criteria
- Must have < 10% marrow blasts
Relapsed or progressive disease or myelodysplasia ≥ 6 months after prior high-dose chemotherapy with autologous hematopoietic cell support
- Prior syngeneic transplantation allowed
Healthy donor meeting one of the following criteria:
HLA-identical sibling (6/6)
- Serologic typing for class I (A, B) and molecular typing for class II (DRB1) required
8/8 matched-unrelated donor
- Molecular identity at HLA A, B, C, and DRB1 by high-resolution typing required
- No syngeneic donors
PATIENT CHARACTERISTICS:
- Creatinine clearance ≥ 40 mL/min
- Total bilirubin ≤ 2 mg/dL
- AST ≤ 3 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- DLCO ≥ 40% with no symptomatic pulmonary disease
- LVEF ≥ 30% by MUGA or ECHO
- No uncontrolled diabetes mellitus or active serious infection
- No known hypersensitivity to E.coli-derived products
- No HIV infection
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks should elapse between prior standard cytotoxic chemotherapy, radiation therapy, or surgery and the planned start of the preparative regimen on day -7
Contacts and Locations| United States, Delaware | |
| Tunnell Cancer Center at Beebe Medical Center | |
| Lewes, Delaware, United States, 19958 | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803-1273 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| Union Hospital of Cecil County | |
| Elkton MD, Maryland, United States, 21921 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Cooper - Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | |
| Columbus, Ohio, United States, 43210-1240 | |
| Principal Investigator: | Asad Bashey, MD, PhD | Blood and Marrow Transplant Group of Georgia |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01118013 History of Changes |
| Other Study ID Numbers: | CDR0000667954, CALGB-100601 |
| Study First Received: | May 5, 2010 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) childhood acute erythroleukemia (M6) 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) juvenile myelomonocytic leukemia prolymphocytic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma recurrent childhood acute myeloid leukemia refractory chronic lymphocytic leukemia recurrent adult Hodgkin 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 childhood grade III lymphomatoid granulomatosis recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Lymphoma Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Lymphoma, Large-Cell, Immunoblastic Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Lymphoma, Non-Hodgkin Antilymphocyte Serum Busulfan Methotrexate Mycophenolate mofetil |
ClinicalTrials.gov processed this record on May 16, 2013