Natural Killer (NK) Cell Adback After Allogeneic Stem Cell Transplant With Campath-IH Plus Chemorx for Patients With Lymphoid Malignancies

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Alemtuzumab; Carmustine; Cyclophosphamide; Cytarabine; Etoposide; Etoposide phosphate; Fludarabine; Fludarabine phosphate; Melphalan; Methotrexate; Rituximab; Tacrolimus; Vidarabine

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

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