NCT01424982

Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia

Active, enrolled Phase 2 Last updated 15 April 2026

What this trial tests

Phase 2 trial testing Cyclophosphamide in Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive in 88 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 October 2011

Primary endpoint
31 October 2027

31 October 2027

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	88
Start date	5 October 2011
Primary completion	31 October 2027
Estimated completion	31 October 2027
Sites	1 location across United States

Drugs / interventions tested

• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Cytarabine
• Dexamethasone (dexamethasone) — full drug profile →
• Doxorubicin
• Doxorubicin Hydrochloride — full drug profile →
• Laboratory Biomarker Analysis
• Methotrexate
• Ponatinib
• Ponatinib Hydrochloride — full drug profile →
• Prednisone (prednisone) — full drug profile →
• Rituximab
• Vincristine
• Vincristine Sulfate

Conditions studied

• Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive — all drugs for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive →
• Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
• Adult Acute Lymphoblastic Leukemia in Complete Remission — all drugs for Adult Acute Lymphoblastic Leukemia in Complete Remission →
• B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 — all drugs for B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive or Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies the side effects and how well combination chemotherapy and ponatinib hydrochloride work in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and ponatinib hydrochloride may be an effective treatment for acute lymphoblastic leukemia.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Combination of hyper-CVAD with ponatinib as first-line therapy for patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia: a single-centre, phase 2 study.
   Jabbour E, Kantarjian H, Ravandi F, Thomas D, et al · · 2015 · cited 208× · PMID 26432046 · DOI 10.1016/s1470-2045(15)00207-7
2. Combination of hyper-CVAD with ponatinib as first-line therapy for patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia: long-term follow-up of a single-centre, phase 2 study.
   Jabbour E, Short NJ, Ravandi F, Huang X, et al · · 2018 · cited 191× · PMID 30501869 · DOI 10.1016/s2352-3026(18)30176-5
3. Inhibition of FGF-FGFR and VEGF-VEGFR signalling in cancer treatment.
   Liu G, Chen T, Ding Z, Wang Y, et al · · 2021 · cited 131× · PMID 33655556 · DOI 10.1111/cpr.13009
4. Frontline combination of ponatinib and hyper-CVAD in Philadelphia chromosome-positive acute lymphoblastic leukemia: 80-months follow-up results.
   Kantarjian H, Short NJ, Jain N, Sasaki K, et al · · 2023 · cited 69× · PMID 36600670 · DOI 10.1002/ajh.26816
5. Prognostic factors for progression in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia in complete molecular response within 3 months of therapy with tyrosine kinase inhibitors.
   Sasaki K, Kantarjian HM, Short NJ, Samra B, et al · · 2021 · cited 56× · PMID 33793964 · DOI 10.1002/cncr.33529
6. How I treat Philadelphia chromosome-positive acute lymphoblastic leukemia.
   Ravandi F. · · 2019 · cited 53× · PMID 30442680 · DOI 10.1182/blood-2018-08-832105
7. Genetic correlates in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia treated with Hyper-CVAD plus dasatinib or ponatinib.
   Sasaki Y, Kantarjian HM, Short NJ, Wang F, et al · · 2022 · cited 27× · PMID 35132195 · DOI 10.1038/s41375-021-01496-8
8. Acute Lymphoblastic Leukemia Immunotherapy Treatment: Now, Next, and Beyond.
   Aureli A, Marziani B, Venditti A, Sconocchia T, et al · · 2023 · cited 25× · PMID 37444456 · DOI 10.3390/cancers15133346