Know Cancer

or
forgot password

A Phase I Study of Milatuzumab (hLL1) for Prevention of Acute Graft Versus Host Disease Following Reduced-Intensity Conditioning Allogeneic Stem Cell Transplant in Patients With Hematologic Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
GVHD (Acute or Chronic), Acute Myeloid or Lymphoblastic Leukemia (AML or ALL), Myelodysplastic Syndrome, Chronic Myelogenous Leukemia (CML), Multiple Myeloma (MM), Non-Hodgekin Lymphoma (NHL-both Follicular & Diffuse Large Cell), Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia (CLL or SLL)

Thank you

Trial Information

A Phase I Study of Milatuzumab (hLL1) for Prevention of Acute Graft Versus Host Disease Following Reduced-Intensity Conditioning Allogeneic Stem Cell Transplant in Patients With Hematologic Malignancies


Inclusion Criteria:



- Males or non-pregnant, non-lactating females, ≥ 18 years of age

- Able to understand and willing to sign informed consent.

- Histologically confirmed hematologic malignancy that is deemed best treated by RIC
allogeneic SCT, including:

- Acute myeloid or lymphoblastic leukemia (AML, ALL) with < 5% blasts in the bone
marrow

- Myelodysplastic syndrome and intermediate-2 or high-risk IPSS score with < 5% blasts
in the bone marrow

- Chronic myelogenous leukemia failing to respond to at least two different tyrosine
kinase inhibitors

- Multiple myeloma that has relapsed following autologous stem cell transplant

- Follicular lymphoma (grades 1, 2, or 3a by WHO criteria) or monocytoid lymphoma that
has relapsed following at least two prior chemotherapy regimens and with either no
lymph node groups ≥ 3 cm or with a ≥ 50% reduction in estimated lymph node diameter
with most recent salvage therapy

- Diffuse large B-cell NHL that has relapsed after at least 2 prior chemotherapy
regimens (could include high-dose chemotherapy with autologous stem cell rescue) and
is still sensitive to chemotherapy by virtue of a PR or CR following most recent
salvage chemotherapy

- Transformed follicular lymphoma that has achieved a PR or CR following chemotherapy

- Mantle cell lymphoma that has relapsed after at least 2 prior chemotherapy regimens
(could include high-dose chemotherapy with autologous stem cell rescue)

- CLL/SLL/PLL that meets one of the following:

- del (17p13.1) in first remission

- Response no better than a PR with chemoimmunotherapy or relapse within 2 years of
chemoimmunotherapy

- Richter's transformation

- Complex karyotype

- At least 4 weeks beyond prior chemotherapy (excluding steroids), antibody therapy,
radiation, or radioimmunoconjugate therapy, and with any kinase inhibitors
discontinued at least one week prior to starting the conditioning regimen.

- ECOG performance status ≤ 2

- Life expectancy of greater than 3 months

- Adequate organ function measured by the following within seven days of beginning
conditioning:

- AST (SGOT) ≤ 3.0 x institutional upper limit of normal (IULN)

- Total bilirubin ≤ 1.5 xIULN unless due to Gilbert's disease

- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min

- DLCO > 40% with no symptomatic pulmonary disease

- LVEF by echocardiogram or MUGA of at least 30%

- Women of child bearing potential and men must agree to use contraception prior to
study entry and for the duration of study participation.

- Matched (8/8) related or matched unrelated donor identified. Haploidentical or
umbilical cord grafts are not allowed.

- Donor willing to donate peripheral blood stem cells and meets institutional criteria
for stem cell donation.

Exclusion Criteria:

- Prior allogeneic stem cell transplant

- Patients requiring a myeloablative conditioning regimen

- Patients best served by a bone marrow transplant are not eligible as this study will
be restricted only to peripheral stem cells.

- No suitable donor identified

- Prior anaphylactic response or Grade 4 infusion reaction to milatuzumab

- 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.

- Patients with active hepatitis B infection are not eligible. Patients with a history
of hepatitis B (surface antigen or core antibody positive) must take lamivudine or
equivalent during study therapy and for one year after completion of milatuzumab.

- LVEF < 30%

- Seropositivity for HIV or Hepatitis C

- Patients with known CNS lymphoma are excluded because of their poor prognosis and
because they often develop progressive neurologic dysfunction that would confound the
evaluation of neurologic and other adverse events.

- Active secondary malignancies with the exception of non-melanomatous skin cancers or
low risk prostate cancer under observation.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety

Outcome Description:

Safety will be measured by physical examinations and hematology and chemistry blood tests. Cardiac safety will be done using MUGA scans or echocardiograms. These assessments will be done routinely during treatment and up to 30 days after treatment and any change from baseline will be assessed. Long term safety will be assessed every 3 months after that for up to 1 year; any change from baseline will be assessed.

Outcome Time Frame:

Safety will be assessed by measuring the change from baseline during 7 days of treatment and up to 30 days after treatment

Safety Issue:

Yes

Principal Investigator

William Wegener, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

IM-T-IMMU-115-03

NCT ID:

NCT01663766

Start Date:

April 2013

Completion Date:

January 2016

Related Keywords:

  • GVHD (Acute or Chronic)
  • Acute Myeloid or Lymphoblastic Leukemia (AML or ALL)
  • Myelodysplastic Syndrome
  • Chronic Myelogenous Leukemia (CML)
  • Multiple Myeloma (MM)
  • Non-Hodgekin Lymphoma (NHL-both Follicular & Diffuse Large Cell)
  • Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia (CLL or SLL)
  • GVHD (acute or chronic)
  • acute myeloid or lymphoblastic leukemia (AML or ALL)
  • myelodysplastic syndrome
  • Chronic myelogenous leukemia (CML)
  • Multiple Myeloma (MM)
  • Non-Hodgekin lymphoma (NHL-both follicular & diffuse large cell)
  • Chronic lymphocytic leukemia or small lymphocytic leukemia (CLL or SLL)
  • Graft vs Host Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Ohio State University Comprehensive Cancer Center Columbus, Ohio