ClinicalTrials.gg
CompletedNCT00060372Updated Mar 27, 2013

Ipilimumab After Allogeneic Stem Cell Transplant in Treating Patients With Persistent or Progressive Cancer

A Phase 1 interventional study of ipilimumab and therapeutic allogeneic lymphocytes in Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) and Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), sponsored by National Cancer Institute (NCI). Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-27.

Primary conditionLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeRegistry: Congenital AbnormalitiesReclassifiedWhy we changed it
Registry
Congenital Abnormalities — the first condition term the registry derived for this study.
ClinicalTrials.gg
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Why
  1. Congenital Abnormalities is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase I trial is studying how well ipilimumab works after allogeneic stem cell transplant in treating patients with persistent or progressive cancer. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine the dose of MDX-010 (ipilimumab) that can safely be administered to patients with persistent or progressive malignancy following allo-HCT.

II. To determine the pharmacokinetics of different doses of MDX-010 administered as a single dose to patients with persistent or progressive malignancy following allo-HCT.

III. By assessment of aims 1 and 2, to determine the best dosing regimen for further study of CTLA-4 blockade in conjunction with escalating dose donor-leukocyte infusions (DLI) in patients with evidence of residual or progressive malignancy following allo-HCT.

IV. To assess if there is preliminary evidence of efficacy following the administration of MDX-010 in this population.

OUTLINE:

Patients receive ipilimumab intravenously (IV) over 90 minutes.

Cohorts of 3-6 patients receive escalating doses of ipilimumab until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients with persistent or progressive disease at 60 days after ipilimumab administration and no evidence of graft-versus-host disease receive donor lymphocyte infusions every 60 days for a total of 3 infusions.

Patients are followed at 4, 5, 6, 9, and 12 months and then annually thereafter.

02

Conditions studied

  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
  • Childhood Myelodysplastic Syndromes
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Disseminated Neuroblastoma
  • Malignant Neoplasm
  • Ovarian Choriocarcinoma
  • Ovarian Embryonal Carcinoma
  • Ovarian Immature Teratoma
  • Ovarian Mature Teratoma
  • Ovarian Mixed Germ Cell Tumor
  • Ovarian Monodermal and Highly Specialized Teratoma
  • Ovarian Polyembryoma
  • Ovarian Yolk Sac Tumor
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Malignant Testicular Germ Cell Tumor
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Neuroblastoma
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Multiple Myeloma
  • Relapsing Chronic Myelogenous Leukemia
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage II Ovarian Epithelial Cancer
  • Stage III Malignant Testicular Germ Cell Tumor
  • Stage III Multiple Myeloma
  • Stage III Ovarian Epithelial Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Testicular Choriocarcinoma
  • Testicular Choriocarcinoma and Embryonal Carcinoma
  • Testicular Choriocarcinoma and Seminoma
  • Testicular Choriocarcinoma and Teratoma
  • Testicular Choriocarcinoma and Yolk Sac Tumor
  • Testicular Embryonal Carcinoma
  • Testicular Embryonal Carcinoma and Seminoma
  • Testicular Embryonal Carcinoma and Teratoma
  • Testicular Embryonal Carcinoma and Teratoma With Seminoma
  • Testicular Embryonal Carcinoma and Yolk Sac Tumor
  • Testicular Embryonal Carcinoma and Yolk Sac Tumor With Seminoma
  • Testicular Teratoma
  • Testicular Yolk Sac Tumor
  • Testicular Yolk Sac Tumor and Teratoma
  • Testicular Yolk Sac Tumor and Teratoma With Seminoma
03

In context

Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Reclassified

209 studies on the registry are indexed under Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; 9 are open to participants now.

This study's enrollment of 21 is below the median of 41 across 131 interventional studies indexed under Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative.

Browse Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Compared within Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Congenital Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Diagnosis of persistent or progressive hematologic or solid tumor after hematopoietic stem cell transplantation (AHSCT)
  • Patients are eligible for study entry at any time between post-transplantation day 90 and 3 years after withdrawal of therapy
  • Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that meets any of the following criteria: hematologic relapse by standard criteria, hematologic persistence evidenced by bone marrow blasts > 10% after day 30 post-AHSCT
  • Cytogenetic progression as evidenced by an increase in the percentage of Philadelphia chromosome (Ph)1-positive metaphases (or Ph1-positive cells by fluorescent in situ hybridization) from complete cytogenetic response (0% Ph1-positive cells) to partial response (1-34% Ph1-positive cells); PR to minor response (35-94% Ph1-positive cells); or MR to no response (95-100% Ph1-positive cells)
  • Resistance to imatinib mesylate, defined as disease progression (hematologic, cytogenetic, or molecular) during OR failure to respond to (i.e., lack of complete hematologic response after 3 months, lack of partial cytogenetic response after 6 months, or lack of complete cytogenetic response after 12 months) prior imatinib mesylate therapy
  • Myelodysplastic syndromes that meet any of the following criteria:

Hematologic relapse by standard criteria, cytogenetic relapse evidenced by recurrence of clonal abnormality in patients who achieved CCR after AHSCT, hematologic persistence evidenced by cytopenias not attributable to other post-transplant causes accompanied by characteristic morphological changes more than 90 days after AHSCT

  • OR; Hematologic persistence evidenced by cytopenias not attributable to other post-transplant causes accompanied by characteristic morphological changes more than 90 days after AHSCT, or cytogenetic persistence evidenced by persistence of clonal abnormality more than 90 days after AHSCT
  • Chronic lymphocytic leukemia that meets any of the following criteria:

greater than 25% increase in absolute lymphocytosis of > 5,000/mm3, greater than 25% increase in measurable lymphadenopathy, persistence of absolute lymphocytosis of > 5,000/mm3 at day 90 or later after AHSCT, persistence of lymphadenopathy of ≥ 3 cm in diameter at day 90 or later after AHSCT

  • Aggressive non-Hodgkin's lymphoma (e.g., diffuse large cell lymphoma, lymphoblastic lymphoma, mantle cell lymphoma, or peripheral T cell lymphoma), Hodgkin's lymphoma, OR solid tumor that meets any of the following criteria: greater than 50% increase in measurable or evaluable disease, persistence of > 3.0 cm in diameter at day 90 or later after AHSCT OR;
  • Persistence of malignancy by or positron emission tomography scan unless there is clear evidence of progression
  • Multiple myeloma with demonstrated resistance to or intolerance of prior thalidomide and bortezomib unless these agents are (e.g., due to peripheral neuropathy) and meeting any of the following criteria: greater than 25% increase in paraprotein band, abnormal quantitative immunoglobulin level, or urine protein excretion OR
  • Greater than 25% increase in percent of plasma cells in the bone marrow (if > 15%), presence of new lytic bone lesions, new extramedullary lesions OR ≥ 25% enlargement of existing extramedullary lesions, persistence of paraprotein band, abnormally elevated quantitative immunoglobulin level, or bone marrow plasmacytosis > 15% for a period of at least 90 days after AHSCT
  • At least 1 bidimensionally measurable lesion ≥ 1.5 cm in diameter
  • Evaluable disease is defined as disease that is assessable for response (e.g., pleural effusion, elevated serum tumor)
  • Bone that can be assessed by CT scan or MRI considered evaluable
  • Leukemia is considered evaluable disease
  • Patients who met criteria for persistence or progression with AML, ALL, CML, or aggressive NHL AND are currently in complete remission after reinduction therapy do not require measurable or evaluable disease to be eligible
  • At least 50% donor chimerism in the T-cell lineage OR full (≥ 90%) donor chimerism in unseparated blood on last assessment within 3 months before study entry
  • No evidence on consecutive testing of > 10% decline in T-cell chimerism beyond the error of the test
  • 0-2
  • : More than 3 months
  • No prior grade 3 or 4 acute graft-vs-host disease
  • No concurrent diseases requiring the chronic use of immunosuppressive medications, active connective tissue disease, CNS disease including multiple sclerosis or demyelinating disease, inflammatory bowel disease, autoimmune hepatitis
  • No ongoing serious infection
  • Negative pregnancy test
  • Fertile patients must use effective during and for at least 4 months after study therapy
  • No other serious ongoing medical condition that would preclude study participation
  • No other malignancy within the past 5 years
  • No psychological or psychiatric condition that would preclude study participation
  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)
  • At least 6 weeks since prior immunosuppressive agents
  • At least 2 weeks since prior imatinib mesylate
  • No concurrent imatinib mesylate
  • At least 6 weeks since prior and no concurrent immunosuppressive agents for clinically active (GVHD) prophylaxis or treatment
  • No other concurrent agents
  • OR Cytogenetic persistence evidenced by any Ph1-positive metaphases in bone marrow after day 90 post-AHSCT
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Treatment (ipilmumab and donor lymphocyte infusion)

    Patients receive ipilimumab IV over 90 minutes. Cohorts of 3-6 patients receive escalating doses of ipilimumab until the MTD is determined. The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients with persistent or progressive disease at 60 days after ipilimumab administration and no evidence of graft-versus-host disease receive donor lymphocyte infusions every 60 days for a total of 3 infusions.

    Drug: ipilimumab · Drug: therapeutic allogeneic lymphocytes

Interventions

  • Given IV

    Also known as: anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody, MDX-010, MDX-CTLA-4, monoclonal antibody CTLA-4

  • Given IV

    Also known as: ALLOLYMPH

06

What researchers measure

Primary outcomes

  1. Incidence of grade 3 and 4 acute GVHD based on NCI CTC

    Time frame: 60 days following administration of ipilimumab

  2. Incidence of graft rejection following ipilimumab defined as the percentage of patients entered who demonstrate =< 10% donor T-cell chimerism

    Time frame: Post-infusion day 60

  3. Autoimmune reaction defined as >= grade 3 dysfunction of a vital organ or the graft

    Time frame: Up to 5 years

Secondary outcomes

  1. Polyclonal T-cell activation monitored by clinical assessment and laboratory evidence (anti CD3, CD4, CD8) and markers of activation (anti CD69, CD25, CD44 and MHC class II)

    Time frame: Up to 5 years

  2. Incidence of extensive stage chronic GVHD

    Time frame: Post-infusion day 360

  3. Disease response

    Time frame: Up to day 360 post ipilimumab infusion

  4. Disease-free survival

    Kaplan- Meier estimates of probability will be used.

    Time frame: Up to day 360 following antibody infusion

  5. Overall survival

    Kaplan- Meier estimates of probability will be used.

    Time frame: Up to 360 days post-infusion

07

Study locations

5 sites
  • Scripps Clinic - La Jolla
    La Jolla, California 92037, United States
  • University of California San Diego
    La Jolla, California 92093-0960, United States
  • Blood and Marrow Transplant Group of Georgia
    Atlanta, Georgia 30342, United States
  • Northside Hospital
    Atlanta, Georgia 30342, United States
  • Dana-Farber Harvard Cancer Center
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • Bashey A, Medina B, Corringham S, Pasek M, Carrier E, Vrooman L, Lowy I, Solomon SR, Morris LE, Holland HK, Mason JR, Alyea EP, Soiffer RJ, Ball ED. CTLA4 blockade with ipilimumab to treat relapse of malignancy after allogeneic hematopoietic cell transplantation. Blood. 2009 Feb 12;113(7):1581-8. doi: 10.1182/blood-2008-07-168468. Epub 2008 Oct 30. PubMed 18974373 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2003 and a primary completion of Apr 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2003
First posted
May 7, 2003
Start
Apr 2003
Primary completionActual
Apr 2008
Last update
Mar 27, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00060372
Responsible party
Sponsor
First posted
May 7, 2003
Start date
Apr 2003
Primary completion
Apr 2008
Last update
Mar 27, 2013

Study contacts

Ewa Carrier
principal investigator · University of California, San Diego
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ipilimumab

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