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Monoclonal Antibody (mAb) 216 With Chemotherapy in Adult Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00313079
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : July 3, 2012
Sponsor:
Information provided by (Responsible Party):
Steven E. Coutre, Stanford University

Tracking Information
First Submitted Date  ICMJE April 7, 2006
First Posted Date  ICMJE April 11, 2006
Last Update Posted Date July 3, 2012
Study Start Date  ICMJE May 2006
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2006)
In this phase I study the endpoint is the determination of the maximum tolerable dose without toxicity.
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2006)
In this phase I study the endpoint is the determination of maximum tolerable dose without toxicity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2008)
A decrease in leukemic blasts. The study will be terminated if unacceptable doseSecondary endpoints are a decrease in leukemic blasts. The study will be terminated if unacceptable dose limiting toxicity is found. This is a phase I trial to study safety.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2006)
  • Secondary endpoints are a decrease in leukemic blasts. The study will be terminated if unacceptable dose
  • limiting toxicity is found. This is a phase I trial to study safety.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monoclonal Antibody (mAb) 216 With Chemotherapy in Adult Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia
Official Title  ICMJE A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Adult Patients With Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia
Brief Summary A phase I trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills B cell acute lymphoblastic leukemia. Trial will study safety, pharmacokinetics, and anti tumor activity of the antibody given as a single agent and with vincristine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia, Lymphocytic
  • Leukemia
  • Acute Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: MAb 216
    Dosage: 1.25mg/kg intravenous with dose escalation
    Other Name: Monoclonal Antibody 216
  • Drug: Vincristine
    Dosage: 1.5mg/m2 intravenous weekly X 4
    Other Names:
    • Oncovin
    • leurocristine
    • VCR
Study Arms  ICMJE Not Provided
Publications * Liedtke M, Twist CJ, Medeiros BC, Gotlib JR, Berube C, Bieber MM, Bhat NM, Teng NN, Coutre SE. Phase I trial of a novel human monoclonal antibody mAb216 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Haematologica. 2012 Jan;97(1):30-7. doi: 10.3324/haematol.2011.045997. Epub 2011 Oct 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2012)
9
Original Enrollment  ICMJE
 (submitted: April 7, 2006)
15
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

3.1.1 Age Patients must be >= 18 years old at the time of study entry.

3.1.2 Diagnosis

3.1.2.1 Histologic Verification Patients must have had histologic verification of B-lineage ALL with bone marrow relapse or refractory disease that is unresponsive to traditional chemotherapy.

3.1.2.2 For patients WITHOUT prior allogeneic BMT:

  1. Second or subsequent bone marrow relapse
  2. Primary refractory marrow disease
  3. M3 marrow (>25% blasts) or >25% leukemic blasts in peripheral blood

3.1.2.3 For patients WITH prior allogeneic BMT:

  1. First or subsequent bone marrow relapse post-BMT
  2. M3 marrow or M2 (>5 % and <25% blasts) if cytogenetic or VNTR confirmation

3.1.3 Confirmation of antibody reactivity 3.1.3.1 Patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mAb 216 in vitro (Teng lab) 3.1.3.2 Patient's RBC documented to NOT express fetal "i" antigen and RBC shown to NOT bind mAb 216 in vitro (Teng lab)

3.1.4 Patient Must Not Be Eligible For Therapies of Higher Priority

3.1.5 Performance Level (See Appendix I) Karnofsky >= 50%

3.1.6 Life Expectancy Must be at least 8 weeks.

3.1.7 Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.

  1. Myelosuppressive chemotherapy: Must not have received within one week of entry onto this study.
  2. Biologic, including monoclonal antibodies: At least 2 weeks since the completion of therapy with a biologic agent including monoclonal antibodies.
  3. Hydroxyurea can be used up to 72 hours before study entry

3.1.8 Organ Function Requirements

3.1.8.1 Bone Marrow Function: 3.1.8.1.1 No hematologic criteria for WBC, Hgb or platelets 3.1.8.1.2 Patients with thrombocytopenia should be responsive to platelet transfusions and must not have uncontrolled bleeding.

3.1.8.2 Adequate Renal Function Defined As:

- A serum creatinine that is less than or equal to 2 x normal for age

3.1.8.3 Adequate Liver Function Defined As:

  • Total bilirubin <= 2 x upper limit of normal (ULN) for age, and
  • SGPT (ALT) <= 5 x upper limit of normal (ULN) for age

3.1.8.4 Adequate Cardiac Function Defined As:

  • Shortening fraction of >= 27% by echocardiogram, or
  • Ejection fraction of >= 50% by gated radionuclide study.

3.1.9 Regulatory

3.1.9.1 All patients must sign a written informed consent. 3.1.9.2 All institutional (IRB) and FDA requirements for human studies must be met.

Exclusion Criteria:

3.2.1 CNS 3 or refractory CNS leukemia

3.2.2 Isolated extramedullary relapse

3.2.3 Uncontrolled infection

3.2.4 Lack of mAb 216 binding to patient's leukemic blasts in vitro

3.2.5 Binding of mAb 216 to the "i" antigen on patient's erythrocytes

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00313079
Other Study ID Numbers  ICMJE HEMALL0003
96613 ( Other Identifier: Stanford University alternate IRB Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven E. Coutre, Stanford University
Study Sponsor  ICMJE Steven E. Coutre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Sub-Investigator: Nelson N Teng Stanford University
PRS Account Stanford University
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP