Natural Killer (NK) Cell Adback After Allogeneic Stem Cell Transplant With Campath-IH Plus Chemorx for Patients With Lymphoid Malignancies
T-Cell or Natural Killer (NK) Cell Adback in Patients With Lymphoid Malignancies Receiving Allogeneic Stem Cell Transplantation With Campath-IH Containing Conditioning Regimens
1 other identifier
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lymphoma
Started Sep 2007
Shorter than P25 for phase_2 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 27, 2007
CompletedFirst Posted
Study publicly available on registry
September 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
May 22, 2012
CompletedSeptember 24, 2020
September 1, 2020
3.2 years
September 27, 2007
April 23, 2012
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-month Treatment Related Mortality (TRM)
Number of participant deaths in 6 months of T- cell or Natural killer (NK) cell adback treatment.
6 Months
Secondary Outcomes (1)
One-year Disease-free Survival (DFS)
1 Year
Study Arms (1)
NK Cell/T-Cell Infusion
EXPERIMENTALPossible 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 \[Fludarabine 30 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)\].
Interventions
100 mg/m\^2 IV Daily Over 1 Hour for 4 Days
15 mg IV Daily Over 30 Minutes for 3 Days
1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days
100 mg/m\^2 IV Daily Over 3 Hours for 4 Days
30 mg/m\^2 IV Daily Over 1 Hour for 3 Days
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.
TBI on Day 5 following chemotherapy, before stem cell infusion.
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.
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.
Eligibility Criteria
You may qualify if:
- Up to 70 years of age.
- 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.
- Patients in relapse or considered at high risk for relapse.
- 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.
- A sibling donor who is 9/10 matched may also be allowed.
- Zubrod PS \</= 2.
- Left ventricular ejection fraction (LVEF)\>/= 40% with no uncontrolled arrythmias or symptomatic heart disease.
- Forced expiratory volume in one second (FEV1), Forced Expiratory Volume (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) \>/= 50%.
- Serum creatinine \< 1.8 mg/dL. Serum bilirubin \< 3 \* upper limit of normal,
- Aspartate aminotransferase (AST) \< 3 \* upper limit of normal.
- Signed, written Internal Review Board (IRB)-approved informed consent.
- 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.
You may not qualify if:
- Past history of anaphylaxis following exposure to CAMPATH-IH or Rituximab
- Patient with active Central Nervous System (CNS) disease.
- 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.
- Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C.
- Patients with other malignancies diagnosed within 2 years prior to Study registration (except skin squamous cell carcinoma).
- Active uncontrolled bacterial, viral or fungal infections.
- Major surgical procedure or significant traumatic injury within 4 weeks prior to Study registration.
- Serious, non-healing wound, ulcer, or bone fracture.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Study registration.
- History of Stroke within 6 months.
- Myocardial infarction within the past 6 months prior to Study registration.
- Uncontrolled chronic diarrhea.
- A prior allogeneic transplant from the same donor. Is there an age limit? Yes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Issa F. Khouri, MD / Professor, Stem Cell Transplantation
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Issa F. Khouri, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2007
First Posted
September 28, 2007
Study Start
September 1, 2007
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
September 24, 2020
Results First Posted
May 22, 2012
Record last verified: 2020-09