Allogeneic Transplantation Using TL1 & ATG for Older Patients With Hematologic Malignancies
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Purpose
To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs.
| Condition | Intervention | Phase |
|---|---|---|
|
Blood Cancer Leukemia |
Drug: cyclosporine Drug: Thymoglobulin Drug: mycophenolate mofetil Drug: g-csf |
Phase 2 |
| 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: | Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies |
- To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
- To evaluate the incidence and extent of chronic GVHD. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
- To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, NK cells and B cells. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
- To evaluate the rate of relapse, overall and event-free survival and transplant related mortality rate. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
- To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Non-myeloablative transplantation |
Drug: cyclosporine
3-5 mg/kg BID; IV or oral
Other Names:
Drug: Thymoglobulin
7.5-10 mg/kg; IV
Other Name: Anti-thymocyte globulin
Drug: mycophenolate mofetil
15 mg/kg BID or Q 8 hours
Other Names:
Drug: g-csf
16 mcg/kg; SQ
Other Names:
|
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
(A) Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic NST is warranted. Specific disease categories include: indolent advanced stage Non-Hodgkin Lymphomas, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin Disease, Acute Leukemias in complete remission, Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, and, Myelodysplastic and Myeloproliferative Syndromes. Patients with other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator.
(B) Patient age > 50 years, or for patients <50 years of age but because of pre-existing medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants.
(C) A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.
(D) Patient must be competent to give consent.
Exclusion Criteria:
(A) Patients with progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission.
(B) Uncontrolled CNS involvement with disease
(C) Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
(D) Females who are pregnant
(E) Organ dysfunction defined as follows:
- Cardiac function: ejection fraction <30% or uncontrolled cardiac failure
- Pulmonary: DLCO <40% predicted
- Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4x the upper limit of normal
- Renal: creatinine clearance <50 cc/min (24 hour urine collection)
(F) Karnofsky performance score < 60%
(G) Patients with poorly controlled hypertension on multiple antihypertensives
(H) Documented fungal disease that is progressive despite treatment
(I) Viral infections: HIV positive patients. Hepatitis B and C positive patients will be evaluated on a case by case basis
(J) Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
Contacts and Locations| Contact: BMT Referrals | (650) 723-0822 | cctoffice@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: BMT Referrals 650-723-0822 cctoffice@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| Principal Investigator: Robert Lowsky | |
| Sub-Investigator: Karl G. Blume | |
| Sub-Investigator: Richard T. Hoppe | |
| Sub-Investigator: Laura Johnston | |
| Sub-Investigator: Robert S Negrin | |
| Sub-Investigator: Judith Anne Shizuru | |
| Sub-Investigator: Samuel Md Strober | |
| Principal Investigator: | Robert Lowsky | Stanford University |
More Information
No publications provided by Stanford University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00185640 History of Changes |
| Obsolete Identifiers: | NCT00186615 |
| Other Study ID Numbers: | BMT153, 78998, BMT153, 11960 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Leukemia Hematologic Neoplasms Neoplasms by Histologic Type Neoplasms Neoplasms by Site Hematologic Diseases Antilymphocyte Serum Cyclosporins Cyclosporine Mycophenolate mofetil Lenograstim Mycophenolic Acid Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic Antineoplastic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 16, 2013