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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00536978
First received: September 27, 2007
Last updated: April 23, 2012
Last verified: April 2012
  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
Radiation: Total body radiation (TBI)
Drug: Methotrexate
Drug: Tacrolimus
Procedure: Adback NK or T Cell
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:
  • 6-month Treatment Related Mortality (TRM) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Number of participant deaths in 6 months of T- cell or Natural killer (NK) cell adback treatment.


Secondary Outcome Measures:
  • One-year Disease-free Survival (DFS) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Efficacy (disease-free-survival) defined as number of participants still living, without disease progression following T- cell or Natural killer (NK) cell adback. One-year disease-free survival (DFS) time estimated using the Kaplan-Meier estimator. Patients who experience disease recurrence considered to be a treatment failure event.


Enrollment: 22
Study Start Date: September 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NK Cell/T-Cell Infusion
Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
Drug: ARA-C
100 mg/m^2 IV Daily Over 1 Hour for 4 Days
Other Names:
  • Cytarbine
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride
Drug: BCNU
300 mg/m^2 IV Over 1 Hour for 1 Day
Other Names:
  • Carmustine
  • BiCNU
Drug: Campath-1H
15 mg IV Daily Over 30 Minutes for 3 Days
Other Names:
  • Alemtuzumab
  • Campath
Drug: Cyclophosphamide
1000 mg/m^2 IV Daily Over 1 Hour for 3 Days
Other Names:
  • Cytoxan
  • Neosar
Drug: Etoposide
100 mg/m^2 IV Daily Over 3 Hours for 4 Days
Other Name: VePesid
Drug: Fludarabine
30 mg/m^2 IV Daily Over 1 Hour for 3 Days
Other Names:
  • Fludarabine Phosphate
  • Fludara
Drug: Melphalan
100 mg/m^2 IV Over 30 Minutes for 1 Day.
Drug: Rituximab
375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks.
Other Name: Rituxan
Other: Allogeneic Stem Cell Transplantation
Stem Cell Infusion on Day 0.
Radiation: Total body radiation (TBI)
TBI on Day 5 following chemotherapy, before stem cell infusion.
Drug: Methotrexate
5 mg/m2 IV on Days +1, +3, and +6.
Drug: Tacrolimus
0.03 mg/kg/day IV starting on Day -2, to be given through day 60, tapered by 20% every week, then discontinue by day 90.
Other Name: Prograf
Procedure: Adback NK or T Cell
Adback natural killer (NK) cells or T cells after transplantation to enhance full engraftment of donor cells. Cell adback after transplantation applies only if there is no active GVHD, and no previous episode of grade II-IV GVHD.

  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, Mucosa-Associated Lymphoid Tissue (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 ejection fraction (LVEF)>/= 40% with no uncontrolled arrythmias or symptomatic heart disease.
  8. Forced expiratory volume in one second (FEV1), Forced Expiratory Volume (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) >/= 50%.
  9. Serum creatinine < 1.8 mg/dL. Serum bilirubin < 3 * upper limit of normal,
  10. Aspartate aminotransferase (AST) < 3 * upper limit of normal.
  11. Signed, written Internal Review Board (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 Central Nervous System (CNS) disease.
  3. Positive Beta human chorionic gonadotrophin (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536978

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00536978     History of Changes
Other Study ID Numbers: 2006-0230
Study First Received: September 27, 2007
Results First Received: April 23, 2012
Last Updated: April 23, 2012
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

Additional relevant MeSH terms:
Leukemia
Lymphoma
Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Alemtuzumab
Cyclophosphamide
Cytarabine
Etoposide
Etoposide phosphate
Fludarabine
Fludarabine phosphate
Melphalan
Methotrexate
Rituximab
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Antiviral Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 24, 2014