Leukemia, LymphocyticPhase 1NCT00313079
Monoclonal Antibody (mAb) 216 With Chemotherapy in Adult Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia
A Phase 1 study testing MAb 216 and Vincristine in people with Leukemia, Lymphocytic and Leukemia, run by Steven E. Coutre at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Leukemia, Acute Lymphocytic Leukemia
- What is being tested?
- MAb 216 and Vincristine
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Second or subsequent bone marrow relapse
- Primary refractory marrow disease
Show all 30Show fewer
- M3 marrow (>25% blasts) or >25% leukemic blasts in peripheral blood
- 3.1.2.3 For patients WITH prior allogeneic BMT:
- First or subsequent bone marrow relapse post-BMT
- 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.
- Myelosuppressive chemotherapy: Must not have received within one week of entry onto this study.
- Biologic, including monoclonal antibodies: At least 2 weeks since the completion of therapy with a biologic agent including monoclonal antibodies.
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Adult Patients With 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.
- Conditions
- Leukemia, Lymphocytic, Leukemia, Acute Lymphocytic Leukemia
- Being tested
- MAb 216, Vincristine
- Medical subject headings
- Leukemia, Lymphoid, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAb 216Drug
Also called Monoclonal Antibody 216
Dosage: 1.25mg/kg intravenous with dose escalation
VincristineDrug
Also called Oncovin, leurocristine, VCR
Dosage: 1.5mg/m2 intravenous weekly X 4
What is being measured
The primary outcome is the main question the study is designed to answer.
In this phase I study the endpoint is the determination of the maximum tolerable dose without toxicity.
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionFeb 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, LymphocyticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven E. Coutre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven E. Coutre, Stanford University
- Investigators
- Nelson N Teng, Sub-investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313079
- Sponsor's protocol ID
- HEMALL0003
- Other IDs
- 96613
- Status last verified
- Jun 2012
- First submitted
- 7 Apr 2006
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21993685
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Adult Patients With Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00313079
- Acronym / sponsor ID
- HEMALL0003
- Conditions
- Leukemia, Lymphocytic, Leukemia, Acute Lymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Steven E. CoutreUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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.
- Second or subsequent bone marrow relapse
- Primary refractory marrow disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAb 216Also: Monoclonal Antibody 216Dosage: 1.25mg/kg intravenous with dose escalation | Drug | – |
| VincristineAlso: Oncovin, leurocristine, VCRDosage: 1.5mg/m2 intravenous weekly X 4 | Drug | – |
Primary outcome
In this phase I study the endpoint is the determination of the maximum tolerable dose without toxicity.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
- Results publication: PubMed 21993685Liedtke 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson N Teng sub-investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MAb 216 and Vincristine in people with Leukemia, Lymphocytic and Leukemia, run by Steven E. Coutre at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In this phase I study the endpoint is the determination of the maximum tolerable dose without toxicity.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00313079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012.