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A Phase I/II Institutional Study of Abraxane in Recurrent and Refractory Lymphoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Lymphoma, Non-Hodgkin, Hodgkin Disease

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Trial Information

A Phase I/II Institutional Study of Abraxane in Recurrent and Refractory Lymphoma

Inclusion Criteria:

- Patient must have histologically confirmed B-cell non-Hodgkin lymphoma or classical
Hodgkin lymphoma:

- Diffuse large B-cell lymphoma (including transformed large cell lymphoma and primary
mediastinal B cell lymphoma)

- Mantle cell lymphoma

- Burkitt's lymphoma

- Follicular lymphoma

- Small lymphocytic lymphoma

- Marginal zone lymphoma

- Lymphoplasmacytic lymphoma

- Classical Hodgkin lymphoma (including nodular sclerosis, mixed cellularity,
lymphocyte rich, and lymphocyte deplete)

- Patient must have measurable disease, defined as the presence of ≥ 1 lymph node or
tumor mass measuring ≥ 1 cm in a single dimension as assessed by CT or MRI.

- Patient must have had prior treatment with ≥ 2 chemotherapy or chemo-immunotherapy
regimens. Prior autologous stem cell transplant is allowed, and prior allogeneic
stem cell transplant is allowed as long as the patient has recovered from acute
toxicities and is off immunosuppression without evidence of graft versus host disease

- Patient must be ≥ 18 years of age.

- Patient must have an ECOG performance status ≤ 2.

- Patient must have adequate bone marrow reserve at the time of therapy initiation,
defined as ANC ≥ 1.0 x 109/L and platelets ≥ 50 x 109/L.

- Patient must have adequate hepatic function, defined as total bilirubin ≤ 1.5 x ULN
and AST/ALT ≤ 3 x ULN.

- Patient must have adequate renal function, defined as serum creatinine ≤ 2.0 x ULN.

- Patient must have recovered from any acute toxicities associated with prior therapy
to ≤ grade 1.

- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study entry and
for the duration of study participation. Should a woman become pregnant or suspect
she is pregnant while participating in this study, she must inform her treating
physician immediately.

- Patient (or legally authorized representative, if applicable) must be able to
understand and willing to sign an IRB approved written informed consent document.

- Both men and women and members of all races and ethnic groups are eligible for this

Exclusion Criteria:

- Patient must not have nodular lymphocyte predominant Hodgkin lymphoma subtype.

- Patient must not have a history of a non-lymphoma malignancy except for the
following: adequately treated localized basal cell or squamous cell carcinoma of the
skin, carcinoma in situ of the cervix, superficial bladder cancer, localized prostate
cancer, any adequately treated stage I or stage II cancer currently in complete
remission, or any other cancer in complete remission for at least 5 years.

- Patient must not be receiving any other investigational agents, and must not have
taken any other investigational agents within ≤ 3 weeks of study entry.

- Patients with Hodgkin's lymphoma must not otherwise be eligible for treatment with
brentuximab vedotin.

- Patient must not have central nervous system or leptomeningeal lymphoma.

- Patient must not have with history of allergic reactions attributed to compounds of
similar chemical or biologic composition to Abraxane.

- Patient must not have any uncontrolled intercurrent illness including, but not
limited to, ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.

- Patient must not be pregnant and/or breastfeeding.

- Patient must not be known to be HIV-positive.

- Patient must not have any pre-existing peripheral neuropathy > grade 1.

- Patient must not have received any chemotherapy, immunotherapy, and/or radiotherapy ≤
3 weeks prior to starting study drug.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Maximum tolerated dose (MTD) of Abraxane in patients with recurrent or refractory lymphoma

Outcome Description:

Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Nina Wagner-Johnston, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

July 2012

Completion Date:

June 2015

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Washington University School of Medicine Saint Louis, Missouri  63110
St. Louis University School of Medicine Saint Louis, Missouri  63104