← Back to Search

Alkylating agents

Chemotherapy + Stem Cell Transplant for Acute Lymphoblastic Leukemia

Phase 2

Waitlist Available

Led By Farhad Ravandi-Kashani

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a morphologic diagnosis of acute lymphoblastic leukemia (ALL) with evidence of ALL involvement in bone marrow and/or blood

Patients must be Philadelphia (Ph) positive and/or BCR/ABL positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying side effects and efficacy of combine chemo w/ or w/o donor stem cell transplant for treating patients w/ acute lymphoblastic leukemia.

Who is the study for?

This trial is for patients with acute lymphoblastic leukemia who have not had more than one prior treatment, are not HIV positive, and do not have significant heart disease or other serious health issues. They must be Philadelphia chromosome or BCR/ABL positive and cannot be pregnant. A matched stem cell donor must be available.Check my eligibility

What is being tested?

The study tests if combination chemotherapy with or without a donor stem cell transplant can effectively treat acute lymphoblastic leukemia. It examines how well multiple drugs work together to stop cancer growth and whether a transplant can help the immune system fight cancer cells.See study design

What are the potential side effects?

Side effects may include damage to organs from chemotherapy drugs, increased risk of infection post-transplant, potential graft-versus-host disease where the donated cells attack the body, fatigue, nausea, hair loss, mouth sores, and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with acute lymphoblastic leukemia affecting my bone marrow or blood.

Select...

My leukemia is Philadelphia chromosome positive.

Select...

I do not have any major heart diseases.

Select...

I achieved complete remission after up to 2 rounds of initial chemotherapy.

Select...

My side effects from previous treatments are mild.

Select...

I can take care of myself and am up and about more than 50% of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation

Secondary outcome measures

Continuous Complete Remission (CCR) Rate

Other outcome measures

MRD as Assessed Using Real-time Quantitative Polymerase Chain Reaction and Flow Cytometry

Overall Survival (OS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (chemotherapy, transplant, maintenance)Experimental Treatment18 Interventions

See Detailed Description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Dasatinib

2012

Completed Phase 3

~2320

Vincristine Sulfate

2005

Completed Phase 3

~10110

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Etoposide

2010

Completed Phase 3

~2440

Sirolimus

2013

Completed Phase 4

~2750

Leucovorin Calcium

2011

Completed Phase 3

~12290

Cytarabine

2016

Completed Phase 3

~3310

Prednisone

2014

Completed Phase 4

~2370

Cyclophosphamide

1995

Completed Phase 3

~3780

Methotrexate

2013

Completed Phase 4

~3800

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Tacrolimus

2011

Completed Phase 4

~4740

Methylprednisolone

2015

Completed Phase 4

~2280

Filgrastim

2000

Completed Phase 3

~3670

Total-Body Irradiation

1997

Completed Phase 3

~1180

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,056 Total Patients Enrolled

Farhad Ravandi-KashaniPrincipal InvestigatorSWOG Cancer Research Network

8 Previous Clinical Trials

609 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00792948 — Phase 2

Chronic Myeloid Leukemia Research Study Groups: Treatment (chemotherapy, transplant, maintenance)

Chronic Myeloid Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00792948 — Phase 2

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00792948 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study allow people who are 35 years or younger to participate?

"According to the standards set for this clinical trial, people aged 18-60 are eligible for enrollment."

Answered by AI

Will this be the first time that this experiment is conducted?

"Vincristine Sulfate has undergone 2598 clinical trials in 3951 cities and 91 countries since 1997. The first study, sponsored by Alfacell, was a Phase 3 drug approval stage that involved 300 participants. 5648 studies have been completed in the years since."

Answered by AI

Can you tell me how many different locations are participating in this trial?

"There are 100 clinical trial sites running this study, including Saint Luke's Regional Medical Center in Sioux City, Mayo Clinic in Rochester, and Ascension Via Christi Hospitals Wichita in Wichita."

Answered by AI

Has Vincristine Sulfate received government sanction for medical use?

"Vincristine Sulfate falls into Phase 2 of clinical trials, meaning that while there is data supporting its safety, more research is needed to confirm efficacy."

Answered by AI

Can new patients still join the clinical trial?

"According to the latest update on clinicaltrials.gov, this research project is not currently looking for volunteers. The trial was first announced on September 1st 2009 but has since been inactive; however, there are 4,150 other trials that might be of interest which are actively recruiting patients right now."

Answered by AI

What other Vincristine Sulfate studies have been completed?

"Currently, there are 2598 studies in operation that involve Vincristine Sulfate. Of those active studies, 584 are in Phase 3. The majority of trials for this treatment take place in Duarte, California; however, there are 87010 locations worldwide where these studies are conducted."

Answered by AI

How can I participate in this research?

"This clinical trial is looking for 97 people between the ages of 18 and 60 who have recurrent adult acute lymphoblastic leukemia (ALL). To be eligible, participants must meet the following criteria: They must have a morphologic diagnosis of ALL with evidence of involvement in bone marrow and/or blood; patients who only have extramedullary disease without bone marrow or blood involvement are not eligible. Additionally, patients with M0 acute myeloid leukemia (AML) or mixed lineage leukemia are not eligible for this study. Patients may have received no more than one course of remission induction therapy for ALL prior to enrolling; patients"

Answered by AI

What are some common reasons why a doctor might prescribe Vincristine Sulfate?

"Vincristine Sulfate is most commonly used to treat merkel cell cancer. It can also help patients with leukemia, synovitis, and scalp structure by inhibiting the proliferation of their condition."

Answered by AI

What is the projected patient enrollment for this clinical trial?

"Unfortunately, this particular study is not searching for additional participants at the moment. However, there are 2598 trials for Vincristine Sulfate and 1552 studies involving recurrent adult acute lymphoblastic leukemia (ALL) that are still recruiting patients."

Answered by AI

Recent research and studies

BloodJournal

Comparable Outcomes of Patients Eligible Vs Ineligible for SWOG Leukemia Studies

Statler, Abby, Megan Othus, Harry P. Erba, Thomas R. Chauncey, Jerald P. Radich, Steven Coutre, Anjali Advani, et al.. 2018. “Comparable Outcomes of Patients Eligible Vs Ineligible for SWOG Leukemia Studies”. Blood. American Society of Hematology. doi:10.1182/blood-2018-01-826693.

clinicaltrials.govStudy

Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

2009. "Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00792948.

All > Stem Cell Transplant > Dasatinib