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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00536978 |
Primary objective:
-To determine the safety of adback T- or Natural Killer (NK) cells in patients with lymphoid malignancies receiving allogeneic stem cell transplantation with Campath-IH containing conditioning regimen.
Secondary objective:
-To determine the efficacy (disease-free-survival) of this strategy.
Condition | Intervention | Phase |
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Lymphoma Leukemia |
Drug: ARA-C Drug: BCNU Drug: Campath-1H Drug: Cyclophosphamide Drug: Etoposide Drug: Fludarabine Drug: Melphalan Drug: Rituximab Other: Allogeneic Stem Cell Transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | T-Cell or Natural Killer (NK) Cell Adback in Patients With Lymphoid Malignancies Receiving Allogeneic Stem Cell Transplantation With Campath-IH Containing Conditioning Regimens |
Estimated Enrollment: | 140 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Campath-IH + BEAM (BCNU, Etoposide,Ara-C, Melphalan) + Rituximab
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Drug: ARA-C
100 mg/m^2 IV Daily Over 1 Hour x 4 Days
Drug: BCNU
300 mg/m^2 IV Over 1 Hour x 1 Day
Drug: Campath-1H
15 mg IV Daily Over 30 Minutes x 3 Days
Drug: Etoposide
100 mg/m^2 IV Daily Over 3 Hours x 4 Days
Drug: Melphalan
100 mg/m^2 IV Over 30 Minutes x 1 Day.
Drug: Rituximab
375 mg/m^2 IV Over 5-7 Hours x 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly x 3 Weeks.
Other: Allogeneic Stem Cell Transplantation
Stem Cell Infusion on Day 0.
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2: Experimental
Fludarabine + Cyclophosphamide + Rituximab + Campath-IH
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Drug: Campath-1H
15 mg IV Daily Over 30 Minutes x 3 Days
Drug: Cyclophosphamide
1000 mg/m^2 IV Daily Over 1 Hour x 3 Days
Drug: Fludarabine
30 mg/m^2 IV Daily Over 1 Hour x 3 Days
Drug: Rituximab
375 mg/m^2 IV Over 5-7 Hours x 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly x 3 Weeks.
Other: Allogeneic Stem Cell Transplantation
Stem Cell Infusion on Day 0.
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Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Issa F. Khouri, MD | 713-745-2803 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Issa F. Khouri, MD |
Principal Investigator: | Issa F. Khouri, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Issa F. Khouri, MD/Professor ) |
Study ID Numbers: | 2006-0230 |
Study First Received: | September 27, 2007 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00536978 |
Health Authority: | United States: Food and Drug Administration |
Lymphoma Leukemia B-Cell Lymphoid Malignancies CLL Cll/Small Lymphocytic Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Diffuse Large Cell Lymphoma Splenic Lymphoma MALT Lymphoplasmacytic Lymphoma Burkitt's Lymphoma |
ARA-C BCNU Campath-1H Cytoxan Etoposide Fludarabine Melphalan Rituximab Allogeneic Stem Cell Transplant T-Cell Cell Adback Natural Killer (NK) Cell Adback |
Melphalan Lymphoma, Mantle-Cell Lymphoma, Follicular Cyclophosphamide Etoposide phosphate Lymphoma, large-cell Leukemia Burkitt's lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Alemtuzumab Waldenstrom macroglobulinemia Etoposide Lymphoma Cytarabine |
Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Carmustine Fludarabine monophosphate Mantle cell lymphoma Lymphatic Diseases Waldenstrom Macroglobulinemia Burkitt Lymphoma Fludarabine Lymphoproliferative Disorders Follicular lymphoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |