NCT00098839|CompletedPhase 1ResultsDMC

Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

A Feasibility Pilot and Phase II Study Of Chemoimmunotherapy With Epratuzumab (IND #12034) for Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia (ALL)

Children's Oncology Group ClinicalTrials.gov

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5 other identifiers

ADVL04P2NCI-2011-01624COG-ADVL04P2CDR0000396777U10CA098543

Study Type

interventional

Target

134

Locations

4 countries

Sites

Timeline

RegisteredDec 2004

StartedFeb 2005

CompletionApr 2011

Brief Summary

This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies, such as epratuzumab, 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. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively.

Trial Health

On Track

Trial Health Score

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

Enrollment

134

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Feb 2005

Longer than P75 for phase_1

Geographic Reach

4 countries

46 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

6.2 years study duration

First Submitted

Initial submission to the registry

December 8, 2004

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2004

Completed

2 months until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed

6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed

4 years until next milestone

Results Posted

Study results publicly available

March 26, 2015

Completed

Last Updated

December 12, 2017

Status Verified

November 1, 2017

Enrollment Period

6.2 years

First QC Date

December 8, 2004

Results QC Date

March 3, 2015

Last Update Submit

November 14, 2017

Conditions

Recurrent Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (3)

Remission Re-induction (CR2) Rate
The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (\<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC \>1000/uL and platelet count \>100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or \< 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count.
At the end of Block 1 of re-induction therapy (day 36)
Event-free Survival Rate
Proportion of patients who were event free at 4 months
At 4 months after enrollment
Rate of Minimal Residual Disease (MRD) < 0.01%
Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD \< 0.01%.
At the end of Block 1 of re-induction therapy (day 36)

Secondary Outcomes (1)

Pharmacokinetics
Up to day 36

Study Arms (2)

Reinduction Chemoimmunotherapy with Epratuzumab once weekly

EXPERIMENTAL

Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.

Drug: L-asparaginaseDrug: doxorubicin hydrochlorideDrug: therapeutic hydrocortisoneDrug: vincristine sulfateBiological: epratuzumabDrug: cytarabineDrug: prednisoneDrug: pegaspargaseDrug: dexrazoxane hydrochlorideDrug: methotrexateDrug: etoposideDrug: cyclophosphamideDrug: leucovorin calciumBiological: filgrastim

Reinduction Chemoimmunotherapy with Epratuzumab twice weekly

EXPERIMENTAL

Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 \& 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.