NCT00089349

Brief Summary

This phase II trial is studying how well giving alemtuzumab with or without methotrexate and mercaptopurine works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as methotrexate and mercaptopurine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

August 4, 2004

Last Update Submit

June 4, 2013

Conditions

Recurrent Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (3)

  • Response rate to Campath-1H alone

    Day 29, course 1

  • Response to combined treatment with Campath-1H and chemotherapy

    Day 29, course 2

  • Tolerability of the combination therapy evaluated by dose-limiting toxicity

    Up to 8 years

Study Arms (1)

Arm I

EXPERIMENTAL

Course 1: Patients receive alemtuzumab IV over 2 hours on days 1-5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission (CR), partial remission (PR), or cytolytic PR at day 29, or patients with CNS disease that achieve a CNS 1 or CNS 2 status, proceed to course 2. Courses 2 and 3: Patients receive alemtuzumab IV over 2 hours on days 1, 8, 15, and 22; methotrexate IV continuously over 24 hours on day 1 and then orally once daily on days 8, 15, and 22; and oral mercaptopurine once daily on days 1-28. Patients with a CR or PR at day 29 proceed to course 3. In course 3, patients receive alemtuzumab, methotrexate, and mercaptopurine as in course 2. CNS prophylaxis\*: Patients receive methotrexate intrathecally on day 1 of courses 2 and 3 on day 1 of courses 2 and 3. NOTE: \* CNS-negative patients receive methotrexate intrathecally on day 15 of course 1 and day 1 of courses 2 and 3.

Biological: alemtuzumabDrug: methotrexateDrug: mercaptopurine

Interventions

alemtuzumabBIOLOGICAL

Given IV

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

Given IV

Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX
Arm I
mercaptopurineDRUG

Given PO

Also known as: 6-mercaptopurine, 6-MP, Leukerin, MP
Arm I

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of acute lymphoblastic leukemia (ALL)
  • Meets 1 of the following criteria:
  • Second or subsequent bone marrow relapse
  • Failed ≥ 2 regimens for remission induction
  • Patients who relapse while receiving standard ALL maintenance chemotherapy do not require a waiting period prior to study entry
  • More than 25% blasts in bone marrow aspirate (M3 marrow)
  • CD52 expression on ≥ 25% of malignant cells at relapse
  • Philadelphia chromosome-positive patients must have failed prior imatinib mesylate
  • Performance status - Karnofsky 50-100% (for patients \> 10 years of age)
  • Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
  • At least 8 weeks
  • ALT ≤ 5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
  • Creatinine normal for age
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COG Phase I Consortium

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

AlemtuzumabMethotrexatemerphosMercaptopurine

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSulfhydryl CompoundsSulfur CompoundsOrganic ChemicalsPurines

Study Officials

  • Anne Angiolillo

    COG Phase I Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

July 1, 2004

Primary Completion

September 1, 2006

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)