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| ID | Type | Description | Link |
|---|---|---|---|
| 96613 | Other Identifier | Stanford University alternate IRB Number |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAb 216 | Drug | Dosage: 1.25mg/kg intravenous with dose escalation |
| |
| Vincristine | Drug | Dosage: 1.5mg/m2 intravenous weekly X 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| In this phase I study the endpoint is the determination of the maximum tolerable dose without toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
3.1.2.3 For patients WITH prior allogeneic BMT:
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.
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:
3.1.8.4 Adequate Cardiac Function Defined As:
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
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| Name | Affiliation | Role |
|---|---|---|
| Nelson N Teng | Stanford University | Sub-Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21993685 | Result | 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. |
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| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |