Phase 2 Lymphoma Trial, Recruiting NCT01371630 Sponsor: M.D. Anderson Cancer Center Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT01371630
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 60 or older who have a type of blood cancer called pre-B ALL (a form of acute lymphoblastic leukaemia) that has not been treated before, including both Philadelphia chromosome-positive and Philadelphia chromosome-negative types. A small amount of prior treatment (less than one week of certain medications, or a single dose of certain chemotherapy drugs) is still allowed.
  • Adults aged 18 to 59 who have the same type of untreated pre-B ALL but who are considered too unwell for standard intensive treatment, and who have at least one significant health condition such as: poor general functioning, serious heart problems, serious lung problems, reduced kidney function, or significant liver problems. (Confirm specific definitions with the trial site.)
  • Adults aged 60 or older who are considered unfit for intensive chemotherapy and have one or more other health conditions such as kidney disease, heart disease, uncontrolled high blood pressure, diabetes, or breathing problems, and whose general health functioning is rated at a certain level. (Confirm with trial site.)
  • People whose general health and functioning falls within an acceptable range on a standard medical scale (rated 0–3 out of 5). (Confirm with trial site.)
  • People with liver and kidney function within certain acceptable ranges, as measured by blood tests. (Confirm specific values with the trial site.)
  • People who are willing and able to provide written consent to participate.
  • People whose ALL is currently in first remission (meaning the cancer has responded to initial treatment).
  • People of any age with ALL that has come back or not responded to treatment, or with certain related types of aggressive blood cancers involving the bone marrow.
  • Jehovah's Witnesses of any age may be eligible.

Who may not be able to join:

  • People who have a newly diagnosed type of blood cancer called Burkitt's Leukaemia or Burkitt's Lymphoma, T-cell ALL, or lymphoblastic lymphoma.
  • People with serious active heart disease at a severe level as assessed by a doctor.
  • People whose heart pumping function (ejection fraction) is measured at below 40%.
  • People with active hepatitis (liver infection or inflammation).
  • People who are pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Elias Jabbour, MD, M.D. Anderson Cancer Center

Phone: 713-792-7026

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
26 August 2011
Est. completion
25 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum tolerated dose of inotuzumab ozogamicin based on incidence of dose limiting toxicities (Phase I); Progression free survival (PFS) in frontline elderly acute lymphoblastic leukemia (ALL) (Phase II); Response rate in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II); Survival in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov