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Natural Killer (NK) Cell Adback After Allogeneic Stem Cell Transplant With Campath-IH Plus Chemorx for Patients With Lymphoid Malignancies
This study is ongoing, but not recruiting participants.
First Received: September 27, 2007   Last Updated: September 1, 2009   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00536978
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To study safety of natural killer (NK) cells and T-cells given to treat leukemia and lymphoma in patients receiving an unrelated donor stem cell transplant after treatment with BEAM, Campath-IH, and rituximab. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To study safety issues of natural killer (NK) cells and T-cells given to treat leukemia and lymphoma patients receiving an unrelated donor stem cell transplant after treatment with low-dose chemotherapy, Campath-IH, rituximab, and TBI. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Up to 70 years of age .
  2. B-cell lymphoid malignancies (those with CD20 negative disease at their diagnosis will not receive rituximab): This includes CLL/small lymphocytic lymphoma, follicular lymphoma, mantle cell, diffuse large cell, Splenic lymphoma, MALT, lymphoplasmacytic lymphoma and Burkitt's lymphoma.
  3. Patients in relapse or considered at high risk for relapse.
  4. In order to increase the chance of KIR-mismatching between recipient and donor, a 9/10 matched (mismatched locus C ) unrelated donor would be preferable. If a mismatched donor is not available, then a fully-matched unrelated donor or other 9/10 matched unrelated donor will be considered.
  5. A sibling donor who is 9/10 matched may also be allowed.
  6. Zubrod PS </= 2.
  7. Left ventricular EF >/= 40% with no uncontrolled arrythmias or symptomatic heart disease.
  8. FEV1, FVC and DLCO >/= 50%.
  9. Serum creatinine < 1.8 mg/dL. Serum bilirubin < 3X upper limit of normal,
  10. AST < 3X upper limit of normal.
  11. Signed, written IRB-approved informed consent.
  12. Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

  1. Past history of anaphylaxis following exposure to CAMPATH-IH or Rituximab
  2. Patient with active CNS disease.
  3. Positive Beta HCG text in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization, or currently breast-feeding.
  4. Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C.
  5. Patients with other malignancies diagnosed within 2 years prior to Study registration (except skin squamous cell carcinoma).
  6. Active uncontrolled bacterial, viral or fungal infections.
  7. Major surgical procedure or significant traumatic injury within 4 weeks prior to Study registration.
  8. Serious, non-healing wound, ulcer, or bone fracture.
  9. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Study registration.
  10. History of Stroke within 6 months.
  11. Myocardial infarction within the past 6 months prior to Study registration.
  12. Uncontrolled chronic diarrhea.
  13. A prior allogeneic transplant from the same donor. Is there an age limit? Yes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536978

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Issa F. Khouri, MD U.T. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by M.D. Anderson Cancer Center:
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009