Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 31, 2026 → Oct 31, 2028
See other at-risk trials from M.D. Anderson Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 31, 2026 to Oct 31, 2028
    • Eligibility criteria expanded, about 6 words
    • Study description revised
  2. 3 versions Re-verified since Jul 29, 2025, no change to tracked fieldsv45-v47
  3. Site contact updatedv44
  4. Site contact updatedv43
  5. Primary and study completion dates: Oct 31, 2024 to Oct 31, 2026v42
Show 40 earlier versionsHide 40 earlier versions
  1. Re-verified, no change to tracked fieldsv41
  2. Primary and study completion dates: Oct 31, 2023 to Oct 31, 2024v40
  3. Re-verified, no change to tracked fieldsv39
  4. Primary and study completion dates: Oct 31, 2022 to Oct 31, 2023v38
  5. 2 versions Re-verified since Jun 14, 2022, no change to tracked fieldsv36-v37
  6. Primary and study completion dates: Oct 31, 2021 to Oct 31, 2022v35
  7. Study description shortened, about 3 wordsv34
  8. Primary and study completion dates: Oct 31, 2020 to Oct 31, 2021v33
  9. Primary and study completion dates: Jul 31, 2019 to Oct 31, 2020v32
  10. Primary endpoints: 1 to 4v31 Show 8 more changesShow less
    • Enrollment target: 130 to 160
    • Primary and study completion dates: Jul 2019 to Jul 31, 2019
    • Interventions: 6-MP (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Dexamethasone (Drug), Doxorubicin (Drug), Mesna (Drug), Methotrexate (Drug)… to Cyclophosphamide (Drug), Cytarabine (Drug), Dexamethasone (Drug), Doxorubicin Hydrochloride (Drug), Mercaptopurine (Drug), Methotrexate…
    • Eligibility criteria expanded, about 15 words
    • Study description expanded, about 419 words
    • Study site revised
    • Collaborator revised
    • Study title expanded, about 8 words
  11. Enrollment target: 100 to 130
    • Study description shortened, about 1,672 words
    v30
  12. Interventions: Cyclophosphamide (Drug), Cytarabine (Drug), Dexamethasone (Drug), Doxorubicin (Drug), Methotrexate (Drug), Nelarabine (Drug), Vincristine… to 6-MP (Drug), Cyclophosphamide (Drug), Cytarabine (Drug), Dexamethasone (Drug), Doxorubicin (Drug), Mesna (Drug), Methotrexate (Drug)…
    • Eligibility criteria shortened, about 6 words
    • Study description expanded, about 154 words
    v29
  13. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 84 to 100
    • Site details revised
    v28
  14. Eligibility criteria expanded, about 6 words
    • Study description expanded, about 1 word
    v27
  15. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 84
    • Start date: Jul 2007 to Jul 11, 2007
    • Site details revised
    v26
  16. Re-verified, no change to tracked fieldsv25
  17. Primary completion date: Jul 2017 to Jul 2019
    • Study completion date: Jul 2019
    • Collaborator revised
    v24
  18. 2 versions Re-verified since Mar 23, 2016, no change to tracked fieldsv22-v23
  19. Eligibility criteria revised
    • Study description shortened, about 3 words
    v21
  20. Enrollment target: 60 to 100
    • Primary completion date: Jul 2016 to Jul 2017
    v20
  21. Study description expanded, about 28 wordsv19
  22. Study description revised
    • Study site revised
    v18
  23. Study description shortened, about 1 wordv17
  24. Primary completion date: Jul 2015 to Jul 2016v16
  25. Eligibility criteria revised
    • Site contact updated
    v15
  26. Collaborators expanded, about 1 wordv14
  27. Primary completion date: Jul 2014 to Jul 2015v13
  28. 4 versions Re-verified since Feb 1, 2012, no change to tracked fieldsv9-v12
  29. Primary completion date: Jul 2012 to Jul 2014
    • Eligibility criteria revised
    • Study description expanded, about 64 words
    v8
  30. Study description shortened, about 166 wordsv7
  31. Primary completion date: Jul 2011 to Jul 2012v6
  32. Eligibility criteria revisedv5
  33. Study site revisedv4
  34. Primary completion date: Jul 2010 to Jul 2011v3
  35. Primary completion date: Jul 2010v2 Show 4 more changesShow less
    • Interventions: Cyclophosphamide (Drug), Cytarabine (Drug), Doxorubicin (Drug), Methotrexate (Drug), Nelarabine (Drug), Vincristine (Drug), dexamethasone… to Cyclophosphamide (Drug), Cytarabine (Drug), Dexamethasone (Drug), Doxorubicin (Drug), Methotrexate (Drug), Nelarabine (Drug), Vincristine…
    • Study description shortened, about 34 words
    • Study arms: 0 to 1
    • Eligibility criteria expanded, about 1 word
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax 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.
Trial Details
NCT Number NCT00501826
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 T Acute Lymphoblastic Leukemia, T Lymphoblastic Lymphoma
Related terms Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov