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Recurrent Childhood Acute Lymphoblastic LeukemiaPhase 2NCT00089349

Alemtuzumab With or Without Methotrexate and Mercaptopurine in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia

A Phase 2 study testing alemtuzumab, methotrexate and mercaptopurine in people with Recurrent Childhood Acute Lymphoblastic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 30 years
What is being tested?
alemtuzumab, methotrexate and mercaptopurine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Jul 2004to Sep 2006
Phase
Phase 2
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 Up to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)
Show all 41Show fewer
  • 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
  • Pulse oximetry > 94%
  • No evidence of dyspnea at rest
  • No exercise intolerance
  • No serious uncontrolled infection
  • No autoimmune hemolytic anemia
  • No autoimmune thrombocytopenia
  • Not pregnant or nursing
  • No nursing for 3 months after study participation
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • Seizure disorder allowed provided patients are on anticonvulsants and symptoms are well controlled
  • CNS toxicity ≤ grade 2
  • No other serious uncontrolled medical condition (e.g., diabetes)
  • Recovered from prior immunotherapy
  • At least 8 weeks since prior biologic agents (e.g., monoclonal antibodies)
  • More than 1 week since prior growth factor(s)
  • At least 4 months since prior stem cell transplantation
  • No evidence of active acute or chronic graft-versus-host disease post allogeneic stem cell transplantation
  • No prior alemtuzumab or its components
  • No other concurrent anticancer immunomodulating agents
  • Recovered from prior chemotherapy
  • One dose of prior intrathecal (IT) methotrexate, cytarabine, and hydrocortisone; IT cytarabine alone; or IT methotrexate alone allowed as part of initial diagnostic spinal tap
  • Prior hydroxyurea therapy allowed
  • No other concurrent anticancer chemotherapy agents
  • Prior steroid therapy allowed
  • More than 2 weeks since prior radiotherapy and recovered

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • COG Phase I Consortium

    Arcadia, California, 91006-3776

Other trials in United States

About this study

Official title: A Phase II Study of Campath-1H in Children With Acute Lymphoblastic Leukemia in Second or Greater Relapse or Twice Induction Failure

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the response rate to alemtuzumab alone and in combination with methotrexate and mercaptopurine in children with acute lymphoblastic leukemia in second or greater relapse or twice induction failure.

II. Determine the toxicity of these regimens in these patients.

SECONDARY OBJECTIVES:

  1. Determine the pharmacokinetics of alemtuzumab in these patients. II. Determine the immune response in patients treated with alemtuzumab. III. Determine changes in the number of CD52-positive cells in the blood and marrow of patients treated with alemtuzumab.

IV. Determine the rate and timing of clearance of peripheral circulating lymphoblasts in patients treated with these regimens.

OUTLINE: This is a multicenter study.

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.

Being tested
alemtuzumab, methotrexate, mercaptopurine
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alemtuzumabBiological

    Also called anti-CD52 monoclonal antibody, Campath-1H, MoAb CD52, Monoclonal Antibody Campath-1H

    Given IV

  • methotrexateDrug

    Also called amethopterin, Folex, methylaminopterin, Mexate

    Given IV

  • mercaptopurineDrug

    Also called 6-mercaptopurine, 6-MP, Leukerin, MP

    Given PO

Study groups in NCT00089349
Study groupRoleWhat they receive
Arm IExperimentalCourse 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.
Receives: Biological: alemtuzumab; Drug: methotrexate; Drug: mercaptopurine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate to Campath-1H alone

    Measured: Day 29, course 1

  2. Response to combined treatment with Campath-1H and chemotherapy

    Measured: Day 29, course 2

  3. Tolerability of the combination therapy evaluated by dose-limiting toxicity

    Measured: Up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2004 (estimated)
  2. Study startJul 2004
  3. Primary completionSep 2006

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089349
Sponsor's protocol ID
NCI-2012-01814
Other IDs
ADVL0222, CDR0000378240, NCI-05-C-0248, COG-ADVL0222, U01CA097452
Status last verified
Jun 2013
First submitted
4 Aug 2004
Last updated
5 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alemtuzumab, methotrexate and mercaptopurine in people with Recurrent Childhood Acute Lymphoblastic Leukemia, run by National Cancer Institute (NCI) 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 41 inclusion and 0 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 5 Jun 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Response rate to Campath-1H alone (time frame: Day 29, course 1). The study lists 3 primary outcomes in all. 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 NCT00089349.

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 5 Jun 2013.

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