Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
M.D. Anderson Cancer Center |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00536978 |
Primary objective:
Secondary objective:
Condition | Intervention | Phase |
---|---|---|
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 |
---|---|
1: Experimental
Campath-IH + BEAM (BCNU, Etoposide,Ara-C, Melphalan) + Rituximab
|
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.
|
2: Experimental
Fludarabine + Cyclophosphamide + Rituximab + Campath-IH
|
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.
|
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T. M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
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: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00536978 History of Changes |
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 |
Antimetabolites Anti-Infective Agents Melphalan Immunologic Factors Lymphoma, Mantle-Cell Lymphoma, Follicular Mantle Cell Lymphoma Cyclophosphamide Etoposide phosphate Follicular Lymphoma Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Alemtuzumab Leukemia, B-cell, Chronic Lymphoma, Large-cell |
Alkylating Agents Lymphoma Etoposide Cytarabine Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Carmustine Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Lymphatic Diseases Burkitt's Lymphoma Chronic Lymphocytic Leukemia Waldenstrom Macroglobulinemia |
Antimetabolites Anti-Infective Agents Melphalan Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Alemtuzumab Therapeutic Uses Lymphoma Etoposide Alkylating Agents |
Cytarabine Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Rituximab Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders |