Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Steven E. Coutre

Stanford Investigator(s):

Intervention(s):

  • Drug: MAb 216
  • Drug: Vincristine

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting