Nonmyeloablative Allogeneic Transplant (Mini-allo)
This study is currently recruiting participants.
Verified January 2011 by Scripps Health
Sponsor:
Scripps Health
Information provided by:
Scripps Health
ClinicalTrials.gov Identifier:
NCT01272817
First received: January 6, 2011
Last updated: January 7, 2011
Last verified: January 2011
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Purpose
Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.
| Condition | Intervention |
|---|---|
|
Aplastic Anemia Paroxysmal Nocturnal Hemoglobinuria Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Mantle Cell Lymphoma Multiple Myeloma Waldenstrom Macroglobulinemia Breast Cancer Renal Cell Carcinoma Melanoma Sarcoma Ovarian Cancer Thymoma |
Procedure: Nonmyeloablative Allogeneic Transplant |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
familial acute myeloid leukemia with mutated CEBPA
paroxysmal nocturnal hemoglobinuria
MedlinePlus related topics:
Acute Myeloid Leukemia
Anemia
Aplastic Anemia
Breast Cancer
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Lymphoma
Melanoma
Multiple Myeloma
Myelodysplastic Syndromes
Ovarian Cancer
Soft Tissue Sarcoma
U.S. FDA Resources
Further study details as provided by Scripps Health:
Primary Outcome Measures:
- Engraftment [ Time Frame: One year ] [ Designated as safety issue: No ]Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant.
Secondary Outcome Measures:
- Graft-versus-host disease [ Time Frame: One year ] [ Designated as safety issue: No ]Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol.
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2001 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cladribine + melphalan
Cladribine + melphalan conditioning
|
Procedure: Nonmyeloablative Allogeneic Transplant
Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
|
|
TLI
Total lymphoid irradiation conditioning
|
Procedure: Nonmyeloablative Allogeneic Transplant
Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)
|
Eligibility| Ages Eligible for Study: | 18 Years to 72 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 55 years or
- Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min
Guidelines for Cladribine-Melphalan-based conditioning:
- Bone Marrow Failure States Severe Aplastic Anemia (relapsed following immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic features or hemosiderosis)
- AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second induction attempt)
- ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse failing reinduction attempt)
- MDS (RAEB, RAEBiT, CMMoL)
- CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy
- Hodgkin's lymphoma (first or greater relapse)
- Non-Hodgkin's Lymphoma
- Aggressive Histology (includes T Cell NHL) Incomplete response to induction Second CR Sensitive or refractory relapse
- Indolent Histology Second or greater relapse
- Mantle Cell Lymphoma (any Stage - must have received induction chemotherapy)
- Multiple Myeloma (10% residual plasmacytosis following anthracycline-based chemotherapy or residual disease following autologous transplant)
- Waldenstrom Macroglobulinemia (must have failed either purine analogue-based chemotherapy (Fludara or 2CdA) or standard CVP therapy; hyperviscosity or cytopenias)
Guidelines for total lymphoid irradiation-based conditioning
- MDS (RA, RARS)
- CLL (Rai stage III or IV - must have received at least two different treatment regimens in the past)
- Breast Cancer (symptomatic metastatic disease, who have failed standard chemotherapy)
- Renal Cell Cancer (metastatic disease at multiple sites)
- Malignant Melanoma (metastatic disease at multiple sites)
- Sarcoma (all subtypes presently, unresectable metastatic disease)
- Ovarian Cancer (stage III or IV, platinum insensitive disease, i.e. progression within 6 months of initial platinum chemotherapy)
- Thymoma (unresectable disease)
Exclusion Criteria:
- Prior allogeneic stem cell or bone marrow transplant
- Current or past history of invasive mycotic infection
- Breast Feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272817
Contacts
| Contact: Carol Burian | 858-554-2845 | burian.carol@scrippshealth.org |
Locations
| United States, California | |
| Scripps Green Hospital | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Cynthia Nelson, R.N. 858-554-2814 nelson.cynthia@scrippshealth.org | |
| Contact: Laurie Cobarrubia, R.N. 858-554-2853 cobarrubia.laurie@scrippshealth.org | |
| Principal Investigator: Jeffrey W. Andrey, M.D. | |
| Sub-Investigator: James R. Mason, M.D. | |
| Sub-Investigator: Edward Kavalerchik, M.D. | |
| Sub-Investigator: William E. Miller, M.D. | |
Sponsors and Collaborators
Scripps Health
Investigators
| Principal Investigator: | Jeffrey W. Andrey, M.D. | Scripps Health |
More Information
No publications provided
| Responsible Party: | Jeffrey W. Andrey, M.D., Scripps Clinic Medical Group |
| ClinicalTrials.gov Identifier: | NCT01272817 History of Changes |
| Other Study ID Numbers: | SCC-01-499 |
| Study First Received: | January 6, 2011 |
| Last Updated: | January 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Scripps Health:
|
Nonmyeloablative transplant Allogeneic transplant Transplant |
Additional relevant MeSH terms:
|
Thymus Neoplasms Anemia Anemia, Aplastic Breast Neoplasms Carcinoma Carcinoma, Renal Cell Hemoglobinuria Hodgkin Disease Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
Lymphoma Lymphoma, Non-Hodgkin Waldenstrom Macroglobulinemia Hemoglobinuria, Paroxysmal Melanoma Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Ovarian Neoplasms Thymoma Lymphoma, Mantle-Cell Sarcoma Hematologic Diseases Bone Marrow Diseases |
ClinicalTrials.gov processed this record on June 17, 2013