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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)
Must not have
Active grade III-V cardiac failure as defined by the New York Heart Association criteria
Active serious infection not controlled by oral or intravenous antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe heart failure.
Select...
I have a serious infection that isn't getting better with antibiotics.
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I do not have serious heart or blood vessel problems.
Select...
I have been treated with ponatinib for more than a month.
Select...
I have had pancreatitis within the last year or suffer from chronic pancreatitis.
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I have a history of a serious bleeding disorder not related to my cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free survival
Secondary study objectives
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%
Fatigue
38%
Decreased appetite
35%
Confusional state
31%
Tachycardia
31%
Diarrhoea
31%
Hypokalaemia
27%
Constipation
27%
Hypophosphataemia
27%
Back pain
23%
Dizziness
23%
Tremor
23%
B-cell lymphoma
23%
Platelet count decreased
23%
White blood cell count decreased
19%
Cough
19%
Agitation
19%
Hyponatraemia
19%
Neutropenia
19%
Tachypnoea
19%
Hypogammaglobulinaemia
19%
Oedema peripheral
15%
Hypomagnesaemia
15%
Thrombocytopenia
15%
Dysphagia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
15%
Chills
15%
Dyspnoea
12%
Aspartate aminotransferase increased
12%
Pain
12%
Arthralgia
12%
Myalgia
12%
Hypertension
12%
Hyperglycaemia
12%
Hypoxia
12%
Vomiting
12%
Abdominal pain
12%
Peripheral sensory neuropathy
12%
Covid-19
12%
Malaise
8%
Dysuria
8%
Muscular weakness
8%
Blood creatinine increased
8%
Hyperhidrosis
8%
Insomnia
8%
Acute myeloid leukaemia
8%
Encephalopathy
8%
Sepsis
8%
Pancytopenia
8%
Eye pain
8%
Urinary tract infection
8%
Lymphocyte count decreased
8%
Asthenia
8%
Somnolence
8%
Oral candidiasis
8%
Pneumonia
8%
Gait disturbance
8%
Aphasia
4%
Pleural effusion
4%
Depression
4%
Embolism
4%
Syncope
4%
Respiratory failure
4%
Febrile neutropenia
4%
Covid-19 pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2650
Prednisone
2014
Completed Phase 4
~2500
Rituximab
1999
Completed Phase 4
~2990
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Vincristine Sulfate
2005
Completed Phase 3
~10270
Doxorubicin
2012
Completed Phase 3
~8030
Methotrexate
2019
Completed Phase 4
~4400
Ponatinib Hydrochloride
2014
Completed Phase 2
~30
Ponatinib
2015
Completed Phase 2
~830
Vincristine
2003
Completed Phase 4
~2970
Cytarabine
2016
Completed Phase 3
~3330
Cyclophosphamide
2010
Completed Phase 4
~2310

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,558 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
16 Previous Clinical Trials
880 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
~6 spots leftby Oct 2025
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