NCT00262925|TerminatedPhase 2Results

Study Stopped

slow accrual

Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

A Phase II Study of MOAD (Methotrexate, Vincristine, L-asparaginase and Dexamethasone) With Subcutaneous Campath for Adults With Relapsed or Refractory Acute Leukemia (ALL)

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2009-00518E1904U10CA021115

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredDec 2005

StartedJun 2006

CompletionFeb 2013

Brief Summary

This phase II trial is studying how well giving combination chemotherapy together with alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with alemtuzumab may kill more cancer cells.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jun 2006

Longer than P75 for phase_2

Geographic Reach

1 country

58 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.7 years study duration

First Submitted

Initial submission to the registry

December 6, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed

6 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed

6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

May 23, 2014

Completed

Last Updated

May 5, 2015

Status Verified

October 1, 2013

Enrollment Period

6.3 years

First QC Date

December 6, 2005

Results QC Date

April 25, 2014

Last Update Submit

April 14, 2015

Conditions

Recurrent Adult Acute Lymphoblastic Leukemia

Keywords

MOADMethotrexateVincristineL-asparaginaseDexamethasoneSubcutaneous Campath

Outcome Measures

Primary Outcomes (1)

Complete Response Rate
Complete response requires that all of the following be present for at least four weeks. 1\. Peripheral Blood Counts: Neutrophil count \>= 1.0 x 109/L, Platelet count \>= 100 x 109/L, Reduced hemoglobin concentration or hematocrit has no bearing on remission status, Leukemic blasts must not be present in the peripheral blood. 2 .Bone Marrow Aspirate and Biopsy: Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines, \<= 5% blasts. 3\. Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
assessed before the first consolidation cycle and first cytoreduction cycle, before the first and after the last maintenance cycle; after discontinuing treatment, assessed every 3 months if < 2 years and every 6 months if 2-5 years from study entry

Secondary Outcomes (1)

Overall Survival
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry

Study Arms (1)

Treatment (chemotherapy, enzyme inhibitor therapy)

EXPERIMENTAL

INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC. CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM. CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone. MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.

Biological: alemtuzumabDrug: asparaginaseDrug: methotrexateDrug: dexamethasoneDrug: leucovorin calciumDrug: mercaptopurineDrug: vincristine

Interventions

alemtuzumabBIOLOGICAL

Given subcutaneously

Also known as: anti-CD52 monoclonal antibody, Campath-1H, MoAb CD52, Monoclonal Antibody Campath-1H, Monoclonal Antibody CD52