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

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

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

Drug Information available for: Cyclophosphamide Cytarabine Cytarabine hydrochloride Etoposide Carmustine Melphalan Fludarabine Fludarabine monophosphate Rituximab Alemtuzumab Etoposide phosphate Melphalan hydrochloride Sarcolysin Campath

U.S. FDA Resources

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

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

Primary Outcome Measures:

To learn the safety of natural killer (NK) cells and T-cells given to treat pts. with leukemia and lymphoma who are 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 the ability of the study treatment to help control the disease. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
To learn the safety of natural killer (NK) cells and T-cells given to treat pts. with leukemia and lymphoma who are 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.

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:

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, 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 EF >/= 40% with no uncontrolled arrythmias or symptomatic heart disease.
FEV1, FVC and DLCO >/= 50%.
Serum creatinine < 1.8 mg/dL. Serum bilirubin < 3X upper limit of normal,
AST < 3X upper limit of normal.
Signed, written 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.

Exclusion Criteria:

Past history of anaphylaxis following exposure to CAMPATH-IH or Rituximab
Patient with active CNS disease.
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.
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

Contacts and Locations

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

Contacts

Contact: Issa F. Khouri, MD

713-745-2803

Locations

United States, Texas
U.T. M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Issa F. Khouri, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Issa F. Khouri, MD

U.T. M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

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:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00536978
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:

Melphalan
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Cyclophosphamide
Etoposide phosphate
Lymphoma, large-cell
Leukemia
Burkitt's lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Waldenstrom macroglobulinemia
Etoposide
Lymphoma
Cytarabine

Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Leukemia, B-cell, chronic
Carmustine
Fludarabine monophosphate
Mantle cell lymphoma
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Burkitt Lymphoma
Fludarabine
Lymphoproliferative Disorders
Follicular lymphoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009