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Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 299 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    4 amendments

    4 re-verifications since 2019-01-22, no change to tracked fields

    v296-v299

  2. Minor

    Site details revised at 1 of 51 sites

    Study Status, Contacts/Locationsv295

  3. Notable

    Phase: Not applicable to Not specified

    Trial status: Withdrawn to Active, Not Recruiting; Primary endpoints: 2 to 3; Enrollment target: 0 to 840; and 6 more

    Show all 10 changes in this update
    • Notable Phase: Not applicable to Not specified
    • Notable Trial status: Withdrawn to Active, Not Recruiting
    • Notable Primary endpoints: 2 to 3
      Show what changed
      Association of novel genes or micorRNAs with other biomarkers
    • Minor Enrollment target: 0 to 840
    • Minor Primary completion date: Jan 2100
    • Minor Interventions: flow cytometry (Other), reverse transcriptase-polymerase chain reaction (Genetic) to laboratory biomarker analysis (Other)
    • Minor Eligibility criteria shortened, about 32 words
      Show what changed
      DISEASEPatients CHARACTERISTICS: Diagnosiswith a diagnosis of 1 of the following diseases: Acuteacute lymphoblastic leukemia (ALL) Patients enrolledentered on CALGB-19802 or anyonto CALGB treatment trials for previously untreated ALL, must be enrolled on thisCALGB trial9862. AcuteEntry on CALGB 8461 is strongly encouraged. Patients with a diagnosis of acute promyelocytic leukemia (APL) Patients enrolled on SWOG- S0521 or SWOG-S0535 for previously untreated APL must be enrolled on thisCALGB trial PATIENT CHARACTERISTICS: Age: Adult Performance status: See Disease Characteristics Life expectancy [...] [...]
    • Minor Secondary endpoints: 4 to 2
      Show what changed
      Association of novel genes or micorRNAs with other biomarkers Blood and bone marrow specimen comparison on the quantitative measurement of MRD
    • Minor Study description shortened, about 67 words
      Show what changed
      OBJECTIVESObjectives: PerformTo perform quantitative polymerase chain reaction (PCR) using known leukemia specific markers in diagnostic bone marrow specimens of patients with newly diagnosed APL and correlateALL and to correlative pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcomes of patients with previously untreated acute lymphoblastic leukemia (ALL) or acute promyelocytic leukemia (APL)outcome. EvaluateTo evaluate the expression of novel genes or microRNAs implicated in di [...] response in pretreatment blood and bone marrow specimens o [...]
    • Minor Study arms: 0 to 1

    Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibilityv294

  4. Minor

    Study Status, Sponsor/Collaborators

    Re-verified, no change to tracked fields

    v293

  5. Stopped

    Trial status: Recruiting to Withdrawn

    Lead sponsor: Cancer and Leukemia Group B to Alliance for Clinical Trials in Oncology; Enrollment target: estimated 450 to confirmed 0; Site details revised at 51 of 51 sites

    Study Identification, Study Status, Sponsor/Collaborators, Study Design, Contacts/Locationsv292

Show 42 earlier versions

  1. Minor

    Study sites: 54 to 51

    Study Status, Contacts/Locationsv291

  2. Minor

    Study sites: 53 to 54

    Study Status, Contacts/Locationsv290

  3. Minor

    Study sites: 54 to 53

    Study Status, Contacts/Locationsv289

  4. Minor

    Study sites: 53 to 54

    Study Status, Contacts/Locationsv288

  5. Minor

    Study sites: 54 to 53

    Study Status, Contacts/Locationsv287

  6. Minor

    Study sites: 53 to 54

    Study Status, Contacts/Locationsv286

  7. Minor

    Study sites: 54 to 53

    Study Status, Contacts/Locationsv285

  8. Minor

    Study sites: 53 to 54

    Study Status, Contacts/Locationsv284

  9. Minor

    Study sites: 54 to 53

    Study Status, Contacts/Locationsv283

  10. Minor

    Study sites: 52 to 54

    Study Status, Contacts/Locationsv282

  11. Minor

    Study sites: 54 to 52

    Study Status, Contacts/Locationsv281

  12. Minor

    Study Status

    Re-verified, no change to tracked fields

    v280

  13. Minor

    Site contacts updated at 1 of 54 sites

    Study Status, Contacts/Locationsv279

  14. Minor

    Study Status

    Re-verified, no change to tracked fields

    v278

  15. Minor

    Study sites: 55 to 54

    Study Status, Contacts/Locationsv277

  16. Minor

    Study sites: 54 to 55

    Study Status, Contacts/Locationsv276

  17. Minor

    Site contacts updated at 1 of 54 sites

    Study Status, Contacts/Locationsv275

  18. Minor

    Study sites: 55 to 54

    Study Status, Contacts/Locationsv274

  19. Minor

    Study sites: 56 to 55

    Study Status, Contacts/Locationsv273

  20. Minor

    Study sites: 55 to 56

    Study Status, Contacts/Locationsv272

  21. Minor

    Study sites: 54 to 55

    Study Status, Contacts/Locationsv271

  22. Minor

    Study sites: 55 to 54

    Study Status, Contacts/Locationsv270

  23. Minor

    Study sites: 53 to 55

    Study Status, Contacts/Locationsv269

  24. Minor

    Study sites: 54 to 53

    Study Status, Contacts/Locationsv268

  25. Minor

    Study sites: 53 to 54

    Study Status, Contacts/Locationsv267

  26. Minor

    Study sites: 54 to 53

    Study Status, Contacts/Locationsv266

  27. Minor

    Study sites: 52 to 54

    Study Status, Contacts/Locationsv265

  28. Minor

    Study sites: 54 to 52

    Study Status, Contacts/Locationsv264

  29. Minor

    Study sites: 49 to 54

    Study Status, Contacts/Locationsv263

  30. Minor

    Study sites: 50 to 49

    Study Status, Contacts/Locationsv262

  31. Minor

    Study sites: 54 to 50

    Study Status, Contacts/Locationsv261

  32. Minor

    Study sites: 53 to 54

    Study Status, Contacts/Locationsv260

  33. Minor

    Study sites: 54 to 53

    Study Status, Contacts/Locationsv259

  34. Minor

    Study sites: 52 to 54

    Study Status, Contacts/Locationsv258

  35. Minor

    Study sites: 51 to 52

    Study Status, Contacts/Locationsv257

  36. Minor

    Study sites: 50 to 51

    Study Status, Contacts/Locationsv256

  37. Minor

    Study sites: 51 to 50

    Study Status, Contacts/Locationsv255

  38. Minor

    Study sites: 50 to 51

    Study Status, Contacts/Locationsv254

  39. Minor

    Study sites: 49 to 50

    Study Status, Contacts/Locationsv253

  40. Minor

    Study sites: 48 to 49

    Study Status, Contacts/Locationsv252

  41. Minor

    Site contacts updated at 1 of 48 sites

    Study Status, Contacts/Locationsv251

  42. Minor

    Study sites revised (48)

    Show what changed: Study sites
    WalterNational Reed ArmyNaval Medical Center

    Study Status, Contacts/Locationsv250

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 research trial studies molecular genetic features in blood and tissue samples from patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia. Studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute promyelocytic leukemia in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Trial Details
NCT Number NCT00003861
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Leukemia, Acute Lymphoblastic Leukemia, Acute Promyelocytic Leukemia
Enrollment 840 participants
Start Date
Primary Completion (estimated)
Updated on ClinicalTrials.gov