AzTrials
AzTrials

LeukemiaPhase 1/2NCT00576979

Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

A Phase 1/2 study testing cyclophosphamide, etoposide and allogeneic bone marrow transplantation in people with Leukemia, run by City of Hope Medical Center 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
Search all trials

Trial summary

RATIONALE: Giving intensity modulated radiation therapy (IMRT) and chemotherapy, such as etoposide and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Read more about this study

Who is it for?
Ages 7 to 55 years
Conditions the study is for
Leukemia
What is being tested?
cyclophosphamide, etoposide and allogeneic bone marrow transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
4 Mar 2008to 7 Jan 2026
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 7 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with acute lymphocytic leukemia or acute myelogenous leukemia who are not in first or second remission (i.e., after failing remission induction therapy or in relapse or beyond second remission)
  • All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C, DR) identical sibling who is willing to donate bone marrow or primed blood stem cells or a 10/10 allele matched unrelated donor; a single allele mismatch at A, B, C, DR, or DQ and a KIR mismatch at C will be allowed; all ABO blood group combinations of the donor/recipient are acceptable since even major ABO compatibilities can be dealt with by various techniques
  • Prior therapy with VP-16, Busulfan, and Cytoxan is allowed
  • A cardiac evaluation with an electrocardiogram showing no ischemic changes or abnormal rhythm and an ejection fraction of >= 50% established by multi gated acquisition scan (MUGA) or echocardiogram
  • Patients must have a serum creatinine of less than or equal to 1.2 or creatinine clearance > 80 ml/min
  • A bilirubin of less than or equal to 1.5
Show all 14Show fewer
  • Serum glutamic oxaloacetic transaminase (SGOT) less than 5 times the upper limit of normal
  • Serum glutamate pyruvate transaminase (SGPT) less than 5 times the upper limit of normal
  • Pulmonary functioning tests including diffusing capacity of carbon monoxide (DLCO) will be performed; forced expiratory volume in one second (FEV1) and DLCO should be greater than 50% of the predicted normal value
  • The time from the end last induction or reinduction attempt should be >= 14 days
  • Signed informed consent form approved by the Institutional Review Board (IRB) is required
  • DONOR: Any sibling donors who are histocompatible with the prospective recipient will be considered a suitable donor
  • Donors will be excluded if for psychological or medical reasons they are unable to tolerate the procedure
  • Donor should be able to donate peripheral blood stem cells or bone marrow

Who cannot join

  • Prior radiation therapy that would exclude the use of total-body irradiation
  • Patients who have undergone bone marrow transplantation previously and who have relapsed
  • Patients with psychological or medical condition that patients physician deems unacceptable to proceed to allogeneic bone marrow transplant
  • Pregnancy
  • Electrocardiogram (EKG) showing ischemic changes or abnormal rhythm and/or an echocardiogram or MUGA scan showing abnormal wall motion or ejection fraction < 50%

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010-3000

Other trials in United States

About this study

Official title: Phase I-II Study of Escalating Doses of Large Field Image-Guided Intensity Modulated Radiation Therapy (IMRT) Using Helical Tomotherapy in Combination With Etoposide (VP16) and Cytoxan as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) Transplantation for Patients With Poor Risk Acute Lymphocytic Leukemia (ALL) or Poor Risk Acute Myelogenous Leukemia (AML)

RATIONALE: Giving intensity modulated radiation therapy (IMRT) and chemotherapy, such as etoposide and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving IMRT together with chemotherapy before transplant may stop this from happening.

PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy (IMRT) when given together with etoposide and cyclophosphamide followed by donor stem cell transplant and to see how well they work in treating patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).

Read the detailed description

OBJECTIVES: I. To establish the maximum tolerated dose [MTD] of large field image-guided IMRT, using helical tomotherapy when given in combination with intravenous cyclophosphamide and VP-16 as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) from an human leukocyte antigen (HLA)-identical sibling or unrelated donor in patients with ALL or AML with induction failure or in relapse. (Phase I) II. To describe the toxicity at each dose level standard. (Phase I) III. To collect data on the radiation dose to normal organs and bone marrow using tomotherapy targeted total-body irradiation (TBI). (Phase I) IV. To estimate the overall survival probability, disease free survival probability and relapse rate associated with this regimen. (Phase II) V. To characterize the treatment related mortality and toxicity profile (early/late) associated with this regimen. (Phase II) VI. To descriptively compare the outcomes of patients treated on this protocol to a comparable patient population conditioned with whole body radiation. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of intensity-modulated radiation therapy (IMRT) followed by a phase II study.

PREPARATIVE REGIMEN: Patients undergo IMRT using helical tomotherapy once or twice daily on days -10 to -6 or -10 to -7. Patients also receive etoposide intravenously (IV) on day -6 or -5 and cyclophosphamide IV on day -4 or -3.

TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day -1 or day 0. After completion of study treatment, patients are followed up periodically for up to 2 years.

Conditions
Leukemia
Keywords
recurrent adult acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia
Medical subject headings
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.

  • cyclophosphamideDrug

    Also called CPM, CTX, Cytoxan, Endoxan

    Given IV

  • etoposideDrug

    Also called EPEG, VP-16, VP-16-213

    Given IV

  • allogeneic bone marrow transplantationProcedure or surgery

    Occurs approximately 48 hours after completion of cyclophosphamide

  • allogeneic hematopoietic stem cell transplantationProcedure or surgery

    Occurs approximately 48 hours after completion of cyclophosphamide

  • peripheral blood stem cell transplantationProcedure or surgery

    Occurs approximately 48 hours after completion of cyclophosphamide

  • intensity-modulated radiation therapyRadiation

    Also called IMRT

    Undergo IMRT

  • tomotherapyRadiation

    Also called helical tomotherapy

    Undergo IMRT using helical tomotherapy

Study groups in NCT00576979
Study groupRoleWhat they receive
Level 1: 1200cGyExperimental150cGy BID x Days 1-4. Total dose 1200cGy.
Receives: Drug: cyclophosphamide; Drug: etoposide; Procedure: allogeneic bone marrow transplantation; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: intensity-modulated radiation therapy; Radiation: tomotherapy
Level 2: 1350cGyExperimental150cGy BID Day 1-4 then 150 cGy QD Day 5. Total dose 1350cGy.
Receives: Drug: cyclophosphamide; Drug: etoposide; Procedure: allogeneic bone marrow transplantation; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: intensity-modulated radiation therapy; Radiation: tomotherapy
Level 3: 1500cGy limited dose to ribs, sternum, liver, brain 1200cGyExperimental150cGy BID Day 1-5. Total dose 1500Gy.
Receives: Drug: cyclophosphamide; Drug: etoposide; Procedure: allogeneic bone marrow transplantation; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: intensity-modulated radiation therapy; Radiation: tomotherapy
Level 4: 1500cGy limited dose to liver, brain 1200cGyExperimental150cGy BID Day 1-5. Total dose 1500Gy.
Receives: Drug: cyclophosphamide; Drug: etoposide; Procedure: allogeneic bone marrow transplantation; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: intensity-modulated radiation therapy; Radiation: tomotherapy
Level 5: 1600cGy limited dose to liver, porta-hepatic, brain 1200cGyExperimental160cGy BID Day 1-5. Total dose 1600Gy.
Receives: Drug: cyclophosphamide; Drug: etoposide; Procedure: allogeneic bone marrow transplantation; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: intensity-modulated radiation therapy; Radiation: tomotherapy
Level 6: 1700cGy limited dose to liver, porta-hepatic, brain 1200cGyExperimental170cGy BID Day 1-5. Total dose 1700Gy.
Receives: Drug: cyclophosphamide; Drug: etoposide; Procedure: allogeneic bone marrow transplantation; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: intensity-modulated radiation therapy; Radiation: tomotherapy
Level 7: 1800cGy limited dose to liver, porta-hepatic, brain 1200cGyExperimental180cGy BID Day 1-5. Total dose 1800Gy.
Receives: Drug: cyclophosphamide; Drug: etoposide; Procedure: allogeneic bone marrow transplantation; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: intensity-modulated radiation therapy; Radiation: tomotherapy
Level 8: 1900cGy limited dose to liver, porta-hepatic, brain 1200cGyExperimental190cGy BID Day 1-5. Total dose 1900Gy.
Receives: Drug: cyclophosphamide; Drug: etoposide; Procedure: allogeneic bone marrow transplantation; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: intensity-modulated radiation therapy; Radiation: tomotherapy
Level 9: 2000cGy limited dose to liver, porta-hepatic, brain 1200cGyExperimental200cGy BID Day 1-5. Total dose 2000Gy.
Receives: Drug: cyclophosphamide; Drug: etoposide; Procedure: allogeneic bone marrow transplantation; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Radiation: intensity-modulated radiation therapy; Radiation: tomotherapy

What is being measured

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

  1. Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I)

    Toxicities will be recorded using two distinct grading systems: the modified Bearman scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0 scale.

    Measured: 30 days post transplant

Timeline

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

  1. First posted19 Dec 2007 (estimated)
  2. Study start4 Mar 2008
  3. Primary completion30 May 2016
  4. Study completion7 Jan 2026

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00576979
Sponsor's protocol ID
05021
Other IDs
CHNMC-05021, CDR0000579141, NCI-2010-00427, R01CA154491
Status last verified
Mar 2026
First submitted
18 Dec 2007
Last updated
24 Mar 2026
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cyclophosphamide, etoposide and allogeneic bone marrow transplantation in people with Leukemia, run by City of Hope Medical Center 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 14 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 24 Mar 2026. 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 11 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I) (time frame: 30 days post transplant). 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 NCT00576979.

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 24 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in