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Alkylating Agent

Chemotherapy + Ponatinib for Acute Lymphoblastic Leukemia

Phase 2
Waitlist Available
Led By Elias Jabbour
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of previously untreated Ph-positive ALL (either t[9;22] and/or bcr-abl positive) or with lymphoid accelerated or blast phase chronic myelogenous leukemia (CML)
Performance status =< 2 (Eastern Cooperative Oncology Group [ECOG] scale)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat leukemia and measure any side effects.

Who is the study for?
This trial is for patients with untreated or previously treated Ph-positive acute lymphoblastic leukemia (ALL) or chronic myelogenous leukemia (CML) in blast phase. Participants must be physically able to perform daily activities with minimal assistance, have normal organ function, and agree to use effective contraception. Excluded are those with serious infections, active hepatitis B, severe heart conditions, uncontrolled blood pressure, a history of significant bleeding disorders unrelated to cancer, or alcohol abuse.Check my eligibility
What is being tested?
The study tests how well a combination of chemotherapy drugs like cyclophosphamide and doxorubicin hydrochloride works alongside ponatinib hydrochloride—a drug that blocks enzymes needed for cancer cell growth—in treating ALL. It's a phase II trial aiming to determine the effectiveness and side effects of this treatment regimen.See study design
What are the potential side effects?
Possible side effects include damage to organs from chemotherapy drugs such as nausea and hair loss; ponatinib may cause issues like high blood pressure or pancreatitis. The severity can vary widely among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific type of leukemia for the first time.
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I can do most of my daily activities on my own.
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I am a woman who can have children and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free survival
Secondary outcome measures
Complete response rate
Disease-specific survival
Incidence of grade 3-4 toxicity according to the M.D. Anderson Leukemia-specific Adverse Event Recording and Reporting Guidelines
+1 more

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401
88%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Hypokalaemia
31%
Diarrhoea
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Dizziness
23%
Platelet count decreased
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Tachypnoea
19%
Agitation
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
15%
Sinus tachycardia
15%
Dysphagia
12%
Vomiting
12%
Hypertension
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Pain
12%
Malaise
12%
Myalgia
12%
Hypoxia
12%
Arthralgia
12%
Hyperglycaemia
12%
Covid-19
12%
Peripheral sensory neuropathy
8%
Hyperhidrosis
8%
Aphasia
8%
Pancytopenia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Gait disturbance
8%
Oral candidiasis
8%
Urinary tract infection
8%
Sepsis
8%
Blood creatinine increased
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Dysuria
8%
Asthenia
8%
Lymphocyte count decreased
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Respiratory failure
4%
Febrile neutropenia
4%
Embolism
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (combination chemotherapy, ponatinib hydrochloride)Experimental Treatment13 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Ponatinib Hydrochloride
2014
Completed Phase 2
~20
Ponatinib
2015
Completed Phase 2
~820
Vincristine Sulfate
2005
Completed Phase 3
~10150
Rituximab
1999
Completed Phase 4
~1880
Prednisone
2014
Completed Phase 4
~2370
Methotrexate
2013
Completed Phase 4
~3800
Vincristine
2003
Completed Phase 4
~2910
Doxorubicin
2012
Completed Phase 3
~7940
Cytarabine
2016
Completed Phase 3
~3310
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,514 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
940 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01424982 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Treatment (combination chemotherapy, ponatinib hydrochloride)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01424982 — Phase 2
Cyclophosphamide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01424982 — Phase 2

Frequently Asked Questions

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~9 spots leftby Oct 2025